A Randomised, Double-blind, Two-period Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin 70/30 and Humulin® 70/30
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy Volunteer
- Sponsor
- Biocon Limited
- Enrollment
- 78
- Locations
- 2
- Primary Endpoint
- Pharmacokinetic endpoints: area under the insulin concentration curve (AUCins) 0-24h
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Two-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover, 24-hour euglycaemic glucose clamp trial in healthy subjects.
Detailed Description
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin 70/30 with Humulin® 70/30 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 dosing. The planned trial duration for each subject is about 12 to 36 days. Eligible subjects will undergo two 24-hour euglycaemic clamp examinations, one after administration of the test product and one after administration of the reference product in random order.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or post-menopausal female subjects. 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 randomization 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.
Outcomes
Primary Outcomes
Pharmacokinetic endpoints: area under the insulin concentration curve (AUCins) 0-24h
Time Frame: 0-24hour
area under the insulin concentration curve
Pharmacokinetic endpoints: insulin concentration (Cins).max
Time Frame: 0-24hour
maximum observed insulin concentration.
Pharmacodynamic Endpoint: Area under curve (AUC)Glucose infusion rate (GIR).0-24h
Time Frame: 0-24hour
area under the glucose infusion rate curve
Pharmacodynamic Endpoint: maximum glucose infusion rate (GIRmax)
Time Frame: 0-24hour
maximum glucose infusion rate
Secondary Outcomes
- Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins) 0-2h(0-2hour)
- Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins)12-24h(12-24hour)
- Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins).0-infinity(0 to 24 hours)
- Pharmacokinetic endpoint: terminal elimination half-life (t½)(0-24hour)
- Pharmacodynamic endpoints: area under the glucose infusion rate curve(AUCGIR)0-12h(0-12hour)
- Pharmacodynamic endpoints: time to half-maximum glucose infusion rate before GIRmax(tGIR.50%-early)(0-24hour)
- Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins) 0-12h(0-12hour)
- Pharmacokinetic endpoint: time(t)50%-ins(early)(0-24hour)
- Pharmacodynamic endpoints: area under the glucose infusion rate curve (AUCGIR)0-6h(0-6hour)
- Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins) 0-6h(0-6hour)
- Pharmacokinetic endpoint: time(t)50%-ins(late)(0-24hour)
- Pharmacokinetic endpoint:terminal elimination rate constant(λz)(0-24hour)
- Pharmacodynamic endpoints: area under the glucose infusion rate curve (AUCGIR)12-24h(12-24hour)
- Pharmacodynamic endpoints: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late)(0-24hour)
- Pharmacodynamic endpoints: Onset of action(0-24hour)
- Pharmacokinetic endpoint: time to maximum observed insulin concentration (tmax)(0-24hour)
- Pharmacodynamic endpoints: area under the glucose infusion rate curve (AUCGIR) 0-2h(0-2hour)
- Pharmacodynamic endpoints: time to maximum glucose infusion rate (tGIR.max)(0-24hour)