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出境医 / 临床实验 / Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R
Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R
Study Description
Brief Summary:
Single-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover,12-hour euglycaemic glucose clamp trial in healthy subjects
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy Volunteer | Biological: Biocon Insulin R Biological: Humulin®R | Phase 1 |
Detailed Description:
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin R with Humulin® R in healthy subjects.
The treatment consists of one single dose of the test or reference product, administered during each of the two study periods, separated by 5-7 days between each dosing.
The planned trial duration for each subject is about 12 to 36 days. Eligible subjects will undergo two 12-hour euglycaemic clamp examinations, one after administration of the test product and one after administration of the reference product in random order.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 42 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | Double-blind |
| Primary Purpose: | Other |
| Official Title: | A Randomised, Double-blind, Two-period Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin R and Humulin® R |
| Actual Study Start Date : | June 18, 2019 |
| Actual Primary Completion Date : | September 15, 2019 |
| Actual Study Completion Date : | September 20, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Biocon Insulin R
0.3 IU/kg Dose per administration, subcutaneous Route of administration
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Biological: Biocon Insulin R
Biocon Insulin R is a short-acting human insulin, produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing Pichia pastoris (yeast).
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Active Comparator: Humulin® R (regular insulin human)
0.3 IU/kg Dose per administration, subcutaneous Route of administration
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Biological: Humulin®R
Humulin® R is a polypeptide hormone structurally identical to human insulin synthesised through recombinant deoxyribonucleic acid (rDNA) technology in a non-pathogenic laboratory strain of Escherichia coli bacteria.
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Outcome Measures
Primary Outcome Measures :
- PK endpoints:Area under the insulin concentration curve(AUCins).0-12h [ Time Frame: 0-12 hours ]Area under the insulin concentration curve from 0 to 12 hours.
- PD endpoints: Area under the glucose infusion rate curve(AUCGIR).0-12h [ Time Frame: 0-12 hours ]Area under the glucose infusion rate curve
- PK endpoints: Maximum observed insulin concentration(Cins.max) [ Time Frame: 0-12 hours ]Maximum observed insulin concentration
- PD endpoints:maximum glucose infusion rate(GIRmax) [ Time Frame: 0-12 hours ]maximum glucose infusion rate
Secondary Outcome Measures :
- PK endpoint- Area under the insulin concentration curve(AUCins).0-2h [ Time Frame: 0 to 2 hours ]Area under the insulin concentration curve
- PK endpoint- Area under the insulin concentration curve(AUCins).0-6h [ Time Frame: 0 to 6 hours ]area under the insulin concentration curve
- PK endpoint- Area under the insulin concentration curve(AUCins).6-12h [ Time Frame: 6 to 12 hours ]area under the insulin concentration curve
- PK endpoint- Area under the insulin concentration curve(AUCins).0-infinity [ Time Frame: 0 hours to 24 hours ]area under the insulin concentration-time curve
- PK endpoint- time to maximum concentration( tmax) [ Time Frame: 0-12 hours ]time to maximum observed insulin concentration.
- PK endpoint- time(t)50%-ins(early) [ Time Frame: 0-12 hours ]time to half-maximum before Cins.max.
- PK endpoint- time(t)50%-ins(late) [ Time Frame: 0-12 hours ]time to half-maximum after Cins.max.
- PK endpoint- terminal elimination half-life (t½) [ Time Frame: 0-12 hours ]terminal elimination half-life calculated as t½=ln2/λz.
- PK endpoint- terminal elimination rate constant (λz) [ Time Frame: 0-12 hours ]terminal elimination rate constant of insulin.
- PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-2h [ Time Frame: 0 to 2 hours ]area under the glucose infusion rate curve
- PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-6h [ Time Frame: 0 to 6 hours ]area under the glucose infusion rate curve
- PD endpoint: area under the glucose infusion rate curve(AUCGIR).6-12h [ Time Frame: 6 to 12 hours ]area under the glucose infusion rate curve
- PD endpoint: time to maximum glucose infusion rate (tGIR.max) [ Time Frame: 0-12 hours ]time to maximum glucose infusion rate
- PD endpoint: time to half-maximum glucose infusion rate before GIRmax (tGIR,50%-early [ Time Frame: 0-12 hours ]time to half-maximum glucose infusion rate before GIRmax
- PD endpoint:time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late) [ Time Frame: 0-12 hours ]time to half-maximum glucose infusion rate after Maximum glucose infusion rate(GIRmax)
- PD endpoint: Onset of action [ Time Frame: 0-12 hours ]ime from trial product administration until blood glucose concentration has decreased at least 5 mg/dL from baseline, where baseline is defined as the mean of blood glucose levels from -6, -4, and -2 minutes before trial product administration as measured by ClampArt®((name of Clamp Devise)
Other Outcome Measures:
- Safety endpoints: Number of subjects with Adverse Events, clinically significant changes in Physical examination, Vital signs. Local tolerability/ Injection site reactions [ Time Frame: First dose to followup period (Total duration: 14 days approximate) ]
Number of subjects with Adverse Events, clinically significant changes in Physical examination, Vital signs
Local tolerability/ Injection site reactions
- Safety endpoint: Number of subjects with clinically significant changes in Laboratory safety parameters, Electrocardiogram (ECG) [ Time Frame: Screening to Follow-up period (Total duration: 35 days approximate) ]
Number of subjects with clinically significant changes in Laboratory safety parameters.
Number of subjects with clinically significant changes in Electrocardiogram (ECG)
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male or post-menopausal female subject. Post-menopausal state is defined as no menses for 12 months without an alternative medical cause and confirmed by a follicle stimulating hormone (FSH) level in the post-menopausal range (>= 25.8 IU/L).
- Age between 18 and 55 years, both inclusive.
- Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2, both inclusive.
- Fasting plasma glucose concentration <= 100 mg/dL.
- Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator
Exclusion Criteria:
- Known or suspected hypersensitivity to Investigational Medicinal products (IMP(s)) or related products.
- Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation in this trial.
- Any history or presence of clinically relevant comorbidity, as judged by the investigator.
- Systolic blood pressure < 95 mmHg or >140 mmHg and/or diastolic blood pressure < 50 mm Hg or > 90 mmHg after resting for at least 5 minutes in supine position (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable).
- Pulse rate at rest outside the range of 50-90 beats per minute.
Contacts and Locations
Locations
| Germany | |
| Profil Mainz GmbH | |
| Mainz, Germany | |
Sponsors and Collaborators
Biocon Limited
Profil Institut für Stoffwechselforschung GmbH
Investigators
| Principal Investigator: | Dr. Leona P Mörschel | Profil Mainz GmbH |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 29, 2019 | ||||
| First Posted Date ICMJE | July 17, 2019 | ||||
| Last Update Posted Date | January 30, 2020 | ||||
| Actual Study Start Date ICMJE | June 18, 2019 | ||||
| Actual Primary Completion Date | September 15, 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 | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R | ||||
| Official Title ICMJE | A Randomised, Double-blind, Two-period Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin R and Humulin® R | ||||
| Brief Summary | Single-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover,12-hour euglycaemic glucose clamp trial in healthy subjects | ||||
| Detailed Description |
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin R with Humulin® R in healthy subjects. The treatment consists of one single dose of the test or reference product, administered during each of the two study periods, separated by 5-7 days between each dosing. The planned trial duration for each subject is about 12 to 36 days. Eligible subjects will undergo two 12-hour euglycaemic clamp examinations, one after administration of the test product and one after administration of the reference product in random order. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Masking Description: Double-blind Primary Purpose: Other
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| Condition ICMJE | Healthy Volunteer | ||||
| 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 |
42 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | September 20, 2019 | ||||
| Actual Primary Completion Date | September 15, 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 | 18 Years to 55 Years (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 | NCT04022317 | ||||
| Other Study ID Numbers ICMJE | EQR | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Biocon Limited | ||||
| Study Sponsor ICMJE | Biocon Limited | ||||
| Collaborators ICMJE | Profil Institut für Stoffwechselforschung GmbH | ||||
| Investigators ICMJE |
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| PRS Account | Biocon Limited | ||||
| Verification Date | January 2020 | ||||
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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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