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出境医 / 临床实验 / Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers(Fed)
Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers(Fed)
Study Description
Brief Summary:
Crossover study to compare the pharmacokinetic characteristics of GLH1SM sustained release tablet and Janumet XR tablet in fed condition
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | Combination Product: Janumet XR tablet 100/1000 mg Combination Product: GLH1SM tablet 100/1000 mg | Phase 1 |
Detailed Description:
2 X 2 crossover study to compare the pharmacokinetic characteristics and safety of GLH1SM sustained release 100/1000mg tablet and Janumet XR 100/1000mg tablet
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 25 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Open-label, Fed, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers |
| Actual Study Start Date : | May 2, 2019 |
| Actual Primary Completion Date : | September 11, 2019 |
| Actual Study Completion Date : | October 23, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: GLH1SM tablet 100/1000 mg in FDC
GLH1SM tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration
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Combination Product: GLH1SM tablet 100/1000 mg
To administrate the GLH1SM tablet
Other Name: Sitagliptin and Metformin in Fixed Dose Combination
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Active Comparator: Janumet XR tablet 100/1000 mg in FDC
Janumet XR tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration
|
Combination Product: Janumet XR tablet 100/1000 mg
To administrate the Janumet XR tablet
Other Name: Sitagliptin and Metformin in Fixed Dose Combination
|
Outcome Measures
Primary Outcome Measures :
- AUCt in ng·h/mL [ Time Frame: 24 hours ]Metformin
- Cmax in ng/mL [ Time Frame: 24 hours ]Metformin
Secondary Outcome Measures :
- AUCinf in ng·h/mL [ Time Frame: 24 hours ]Metformin
- Tmax in hour [ Time Frame: 24 hours ]Metformin
- t1/2 in hour [ Time Frame: 24 hours ]Metformin
- CL/F in Liter/min/kg [ Time Frame: 24 hours ]Metformin
- Vd/F in Liter/kg [ Time Frame: 24 hours ]Metformin
Other Outcome Measures:
- Adverse events [ Time Frame: 1 day before IP administration, 1 day, 2 day, 3 day of each period, and one day between 3 day and 7 day after last blood sampling ]To 28 days after last IP administration
- Vital signs in blood pressure [ Time Frame: Screening(between 2 day and 28 day before IP administration), 1 day and 3 day of each period, and one day between 3 day and 7 day after last blood sampling ]Blood pressure(SBP, DBP)
- Vital signs in pulse [ Time Frame: Screening(between 2 day and 28 day before IP administration), 1 day and 3 day of each period, and one day between 3 day and 7 day after last blood sampling ]Pulse rate
- Vital signs in temperature [ Time Frame: Screening(between 2 day and 28 day before IP administration), 1 day and 3 day of each period, and one day between 3 day and 7 day after last blood sampling ]eardrum
- Physical examinations in weight [ Time Frame: Screening(between 2 day and 28 day before IP administration), 1 day before IP administration, 1 day, 2 day, 3 day of each period, and one day between 3 day and 7 day after last blood sampling ]Weight in kilograms
- Physical examinations in height [ Time Frame: Screening(between 2 day and 28 day before IP administration), 1 day before IP administration, 1 day, 2 day, 3 day of each period, and one day between 3 day and 7 day after last blood sampling ]Height in meters
- Clinical laboratories in blood sample [ Time Frame: Screening(between 2 day and 28 day before IP administration), 1 day before IP administration, and 3 day of each period, and one day between 3 day and 7 day after last blood sampling ]Normal blood chemistry, Type B hepatitis, Type C hepatitis, HIV, and Syphilis
- 12-lead ECG in clinical significance [ Time Frame: Screening(between 2 day and 28 day before IP administration), and one day between 3 day and 7 day after last blood sampling ]QRS complex
Eligibility Criteria
| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male subjects who, at the time of screening, are the age of older than 19 years
- Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg
- There is no congenital disease or within 3 years of chronic diseases
- Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG) or clinical laboratory tests
- Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
- A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products
- A subject who has the following clinical laboratory test results Liver Function Test (AST, ALT) > two times the upper limit of the normal range
- History of regular alcohol consumption exceeding 210g/week(12g = 125 mL of wine, 10g = 250 mL of beer, 10g = 50 mL of hard liquor) within 6 months of Screening
- A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product. (The end date of another clinical trial is based on the last day of the administration)
- A subject with a history of drug abuse or a positive urine drug screening for drug abuse within 1 year
- A subject who has taken the drugs that induce and suppress drug- metabolizing enzymes within 30 days prior to investigational product administration
- A smoker who consumes more than 20 cigarettes/day within 6 months
- A subject who has taken any ethical-the-counter drug or has taken any over- the-counter drug within 10 days before the investigational product administration
- A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
- Acute effects that may affect renal function in patients with moderate and severe renal failure (eGFR<45 mL/min/1.73m2) such as sepsis, dehydration, severe infection, cardiovascular collapse, acute myocardial infarction
- Acute and unstable heart failure
- Patients receiving intravenous administration of radiation iodine contrast media (eg, intravenous urography, venous cholangiography, angiography, computed tomography using contrast media, etc.)
- Patients who are known to be hypersensitive to anaphylaxis or angioedema for the drug or its components
- Patients with acute or chronic metabolic acidosis, including type 1 diabetes, diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis
- Patients with severe infectious disease or severe traumatic systemic disorder
- Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs
- Pregnant women, women who may be pregnant, breastfeeding
- A subject who is not eligible for the study due to reasons on the investigators' judgement
Contacts and Locations
Locations
| Korea, Republic of | |
| Chonbuk National University Hospital | |
| Jeonju, Jeollabuk-do, Korea, Republic of, 54907 | |
Sponsors and Collaborators
GL Pharm Tech Corporation
Investigators
| Principal Investigator: | Kyungho Jang, MD, Ph.D | Chonbuk National University Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 23, 2019 | ||||
| First Posted Date ICMJE | April 25, 2019 | ||||
| Last Update Posted Date | July 23, 2020 | ||||
| Actual Study Start Date ICMJE | May 2, 2019 | ||||
| Actual Primary Completion Date | September 11, 2019 (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 | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures |
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| Descriptive Information | |||||
| Brief Title ICMJE | Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers(Fed) | ||||
| Official Title ICMJE | A Randomized, Open-label, Fed, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers | ||||
| Brief Summary | Crossover study to compare the pharmacokinetic characteristics of GLH1SM sustained release tablet and Janumet XR tablet in fed condition | ||||
| Detailed Description | 2 X 2 crossover study to compare the pharmacokinetic characteristics and safety of GLH1SM sustained release 100/1000mg tablet and Janumet XR 100/1000mg tablet | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Healthy | ||||
| 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 |
25 | ||||
| Original Estimated Enrollment ICMJE |
30 | ||||
| Actual Study Completion Date ICMJE | October 23, 2019 | ||||
| Actual Primary Completion Date | September 11, 2019 (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 | 19 Years and older (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 | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03927170 | ||||
| Other Study ID Numbers ICMJE | GLH1SM-102 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | GL Pharm Tech Corporation | ||||
| Study Sponsor ICMJE | GL Pharm Tech Corporation | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | GL Pharm Tech Corporation | ||||
| Verification Date | September 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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