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出境医 / 临床实验 / Investigation How CG5503 is Taken up and Excreted From the Body After 2 Minutes Intravenous Infusion With and Without Oral Co-administration of Charcoal
Investigation How CG5503 is Taken up and Excreted From the Body After 2 Minutes Intravenous Infusion With and Without Oral Co-administration of Charcoal
Study Description
Brief Summary:
This was a Phase I study in 12 healthy male participants to compare the pharmacokinetic properties of CG5503 (how it is taken up and excreted from the body) after 2 minutes intravenous (i.v.) infusion with and without oral co-administration of charcoal to investigate a potential gastrointestinal secretion of CG5503.
During the course of the study each participant received two infusions of 40 mg CG5503 without (treatment A) and with (treatment B) oral co-administration of charcoal. In treatment B, eight doses of 5 grams charcoal powder were co-administered orally at defined time points. The wash out phases were to be at least 4 to 14 days between the treatment periods.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pharmacokinetic | Drug: 4 ml CG5503 Drug: 5 g charcoal powder | Phase 1 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | The randomization was in the ratio 1:1. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Investigation of the Pharmacokinetic Properties of CG5503 After 2 Minutes Intravenous Infusion With and Without Oral Coadministration of Charcoal in a Randomised, Open, Single Dose, 2-way Crossover, Phase I Study in 12 Healthy Male Volunteers |
| Actual Study Start Date : | February 2004 |
| Actual Primary Completion Date : | April 2004 |
| Actual Study Completion Date : | April 2004 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment A: 4 ml CG5503
4 ml of the CG5503 i.v. infusion solution corresponding to 40 mg CG5503 (tapentadol hydrochloride) was administered as a 2 minutes infusion.
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Drug: 4 ml CG5503
4 ml of the CG5503 infusion solution corresponding to 40 mg CG5503 (tapentadol hydrochloride).
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Experimental: Treatment B: 4 ml CG5503; 5 g charcoal powder
4 ml of the CG5503 i.v. infusion solution corresponding to 40 mg CG5503 (tapentadol hydrochloride) with oral co-administration of charcoal (5 g charcoal were co-administered orally at 1, 0.5 hours and 10 minutes before the start of CG5503 infusion and 0.5, 1, 1.5, 2 and 4 hours thereafter)
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Drug: 4 ml CG5503
4 ml of the CG5503 infusion solution corresponding to 40 mg CG5503 (tapentadol hydrochloride).
Drug: 5 g charcoal powder Oral administration of 5 g charcoal powder suspended in 100 ml tap water.
Other Name: Tradename: Kohle-Pulvis Pulver
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Outcome Measures
Primary Outcome Measures :
- Pharmacokinetic parameter Serum: area under the concentration-time curve extrapolated to infinity (AUC0-inf) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The AUC0-inf was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Saliva: area under the concentration-time curve extrapolated to infinity (AUC0-inf) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]16 PK saliva samples were obtained from each participant. Saliva concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. Participants were asked to donate saliva as much as possible in approximately 0.5 minutes. The AUC0-inf was calculated based on saliva concentration-time data (using the actual saliva sampling time intervals).
- Pharmacokinetic parameter Serum: area under the concentration-time curve extrapolated to infinity (AUC0-inf) for CG5503-glucuronide [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The AUC0-inf was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: area under the concentration-time curve extrapolated to infinity (AUC0-inf) for CG5503-sulphate [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The AUC0-inf was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: area under the concentration-time curve from 0 to time t (AUC0-t) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The AUC0-t was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Saliva: area under the concentration-time curve from 0 to time t (AUC0-t) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]16 PK saliva samples were obtained from each participant. Saliva concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. Participants were asked to donate saliva as much as possible in approximately 0.5 minutes. The AUC0-t was calculated based on saliva concentration-time data (using the actual saliva sampling time intervals).
- Pharmacokinetic parameter Serum: area under the concentration-time curve from 0 to time t (AUC0-t) for CG5503-glucuronide [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The AUC0-t was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: area under the concentration-time curve from 0 to time t (AUC0-t) for CG5503-sulphate [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The AUC0-t was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: maximum concentration (Cmax) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The Cmax was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Saliva: maximum concentration (Cmax) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]16 PK saliva samples were obtained from each participant. Saliva concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. Participants were asked to donate saliva as much as possible in approximately 0.5 minutes. tubes. The Cmax was calculated based on saliva concentration-time data (using the actual saliva sampling time intervals).
- Pharmacokinetic parameter Serum: maximum concentration (Cmax) for CG5503-glucuronide [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The Cmax was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: maximum concentration (Cmax) for CG5503-sulphate [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The Cmax was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: time to maximum concentration (tmax) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The tmax was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Saliva: time to maximum concentration (tmax) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]16 PK saliva samples were obtained from each participant. Saliva concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. Participants were asked to donate saliva as much as possible in approximately 0.5 minutes. The tmax was calculated based on saliva concentration-time data (using the actual saliva sampling time intervals).
- Pharmacokinetic parameter Serum: time to maximum concentration (tmax) for CG5503-glucuronide [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The tmax was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: time to maximum concentration (tmax) for CG5503-sulphate [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The tmax was calculated based on serum concentration-time data (using the actual blood sampling times).
Secondary Outcome Measures :
- Pharmacokinetic parameter Serum: extrapolated AUC expressed as a percentage of total AUC0-inf (AUC%extr) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The AUC%extr was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Saliva: extrapolated AUC expressed as a percentage of total AUC0-inf (AUC%extr) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]16 PK saliva samples were obtained from each participant. Saliva concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. Participants were asked to donate saliva as much as possible in approximately 0.5 minutes. The AUC%extr was calculated based on saliva concentration-time data (using the actual saliva sampling time intervals).
- Pharmacokinetic parameter Serum: extrapolated AUC expressed as a percentage of total AUC0-inf (AUC%extr) for CG5503-glucuronide [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The AUC%extr was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: extrapolated AUC expressed as a percentage of total AUC0-inf (AUC%extr) for CG5503-sulphate [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The AUC%extr was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: apparent terminal elimination rate constant (λz) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The λz was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Saliva: apparent terminal elimination rate constant (λz) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]16 PK saliva samples were obtained from each participant. Saliva concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. Participants were asked to donate saliva as much as possible in approximately 0.5 minutes. The λz was calculated based on saliva concentration-time data (using the actual saliva sampling time intervals).
- Pharmacokinetic parameter Serum: apparent terminal elimination rate constant (λz) for CG5503-glucuronide [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The λz was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: apparent terminal elimination rate constant (λz) for CG5503-sulphate [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The λz was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: the apparent half-life associated with the terminal elimination phase (t1/2,z) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The t½z was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Saliva: the apparent half-life associated with the terminal elimination phase (t1/2,z) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]16 PK saliva samples were obtained from each participant. Saliva concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. Participants were asked to donate saliva as much as possible in approximately 0.5 minutes. The t½z was calculated based on saliva concentration-time data (using the actual saliva sampling time intervals).
- Pharmacokinetic parameter Serum: the apparent half-life associated with the terminal elimination phase (t1/2,z) for CG5503-glucuronide [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The t½z was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: the apparent half-life associated with the terminal elimination phase (t1/2,z) for CG5503-sulphate [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The t½z was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: total serum or blood clearance of drug after intravenous administration (CL) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The CL was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Saliva: total clearance of drug after intravenous administration (CL) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]16 PK saliva samples were obtained from each participant. Saliva concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. Participants were asked to donate saliva as much as possible in approximately 0.5 minutes. The CL was calculated based on saliva concentration-time data (using the actual saliva sampling time intervals).
- Pharmacokinetic parameter Serum: total serum or blood clearance of drug after intravenous administration (CL) for CG5503-glucuronide [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The CL was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: total serum or blood clearance of drug after intravenous administration (CL) for CG5503-sulphate [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The CL was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: the apparent volume of distribution associated with terminal phase after intravenous administration (Vz) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The Vz was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Saliva: the apparent volume of distribution associated with terminal phase after intravenous administration (Vz) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]16 PK saliva samples were obtained from each participant. Saliva concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. Participants were asked to donate saliva as much as possible in approximately 0.5 minutes. The Vz was calculated based on saliva concentration-time data (using the actual saliva sampling time intervals).
- Pharmacokinetic parameter Serum: the apparent volume of distribution associated with terminal phase after intravenous administration (Vz) for CG5503-glucuronide [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The Vz was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Serum: the apparent volume of distribution associated with terminal phase after intravenous administration (Vz) for CG5503-sulphate [ Time Frame: Pre-dose and up to 23 hours post-dose ]26 PK blood samples were obtained from each participant. Serum concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The Vz was calculated based on serum concentration-time data (using the actual blood sampling times).
- Pharmacokinetic parameter Urine: renal excretion (Ae % of dose) for CG5503 base [ Time Frame: Pre-dose and up to 23 hours post-dose ]12 PK urine samples were obtained from each participant. Urine concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The Ae (% of dose) was calculated based on urine concentration-time data (using the actual urine sampling time intervals).
- Pharmacokinetic parameter Urine: renal excretion (Ae % of dose) for CG5503-glucuronide [ Time Frame: Pre-dose and up to 23 hours post-dose ]12 PK urine samples were obtained from each participant. Urine concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The Ae (% of dose) was calculated based on urine concentration-time data (using the actual urine sampling time intervals).
- Pharmacokinetic parameter Urine: renal excretion (Ae % of dose) for CG5503-sulphate [ Time Frame: Pre-dose and up to 23 hours post-dose ]12 PK urine samples were obtained from each participant. Urine concentrations were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays. The Ae (% of dose) was calculated based on urine concentration-time data (using the actual urine sampling time intervals).
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male Caucasian participants aged 18 - 65 years.
- Body mass index (BMI) between 20 and 30 kilograms/square meter inclusive.
- Participants must be in good health as determined by medical history, physical examination, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters (serum/urine biochemistry, serology and haematology). Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance and if not considered to interfere with the study objectives.
- Negative human immunodeficiency virus (HIV)-1/-2 antibodies, hepatitis B surface (HBs)-antigen, hepatitis B core (HBc)-antibodies, hepatitis C virus (HCV)-antibodies at the screening examination.
- Participants giving written consent to participate within this trial.
Exclusion Criteria:
- Use of any medication within four weeks prior to commencement of the study (self-medication or prescription), if not on a stable basis.
- Diseases and functional disorders of the gastrointestinal tract, liver, cardiovascular system or kidneys.
- Malignancy.
- History of orthostatic hypotension.
- Resting pulse rate equal to or below 45 beats/min or equal to or above 100 beats/min.
- Systolic blood pressure equal to or below 100 mmHg or equal to or above 160 mmHg.
- Diastolic blood pressure equal to or below 50 mmHg or equal to or above 95 mmHg.
- Clinically relevant deviations in laboratory parameters.
- Drug allergy.
- Bronchial asthma.
- Participation in another clinical study in the last three months before starting this study (exception: characterization of metabolizer status).
- Blood donation (more than 100 milliliter) in the last three months before the start of the study.
- Evidence of alcohol or drug abuse.
- Positive drug abuse screening test.
- Extremely unbalanced diet (in the opinion of the investigator).
- Excessive consumption of food or beverages containing caffeine (more than five cups of coffee per day or other equivalent amounts of caffeine).
- Consumption of grapefruit juice two weeks before the start of the study.
- Known or suspected of not being able to comply with the study protocol.
- Not able to communicate meaningfully with the investigator and staff.
- Neurotic personality, psychiatric illness, or suicide risk.
- History of seizures or at risk (i.e. head trauma, epilepsy in family anamnesis, unclear loss of consciousness).
Contacts and Locations
Locations
| Germany | |
| Department of Clinical Pharmacology Grünenthal GmbH | |
| Aachen, Germany, 52099 | |
Sponsors and Collaborators
Grünenthal GmbH
Investigators
| Study Director: | Grünenthal Study Director | Grünenthal GmbH |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 14, 2019 | ||||
| First Posted Date ICMJE | May 16, 2019 | ||||
| Last Update Posted Date | May 16, 2019 | ||||
| Actual Study Start Date ICMJE | February 2004 | ||||
| Actual Primary Completion Date | April 2004 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Investigation How CG5503 is Taken up and Excreted From the Body After 2 Minutes Intravenous Infusion With and Without Oral Co-administration of Charcoal | ||||
| Official Title ICMJE | Investigation of the Pharmacokinetic Properties of CG5503 After 2 Minutes Intravenous Infusion With and Without Oral Coadministration of Charcoal in a Randomised, Open, Single Dose, 2-way Crossover, Phase I Study in 12 Healthy Male Volunteers | ||||
| Brief Summary |
This was a Phase I study in 12 healthy male participants to compare the pharmacokinetic properties of CG5503 (how it is taken up and excreted from the body) after 2 minutes intravenous (i.v.) infusion with and without oral co-administration of charcoal to investigate a potential gastrointestinal secretion of CG5503. During the course of the study each participant received two infusions of 40 mg CG5503 without (treatment A) and with (treatment B) oral co-administration of charcoal. In treatment B, eight doses of 5 grams charcoal powder were co-administered orally at defined time points. The wash out phases were to be at least 4 to 14 days between the treatment periods. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: The randomization was in the ratio 1:1. Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Pharmacokinetic | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
14 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | April 2004 | ||||
| Actual Primary Completion Date | April 2004 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03951987 | ||||
| Other Study ID Numbers ICMJE | HP5503/11 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Grünenthal GmbH | ||||
| Study Sponsor ICMJE | Grünenthal GmbH | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Grünenthal GmbH | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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