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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy Volunteer
- Sponsor
- Biocon Limited
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- PD endpoints: Area under the glucose infusion rate curve(AUCGIR).0-12h
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
PD endpoints: Area under the glucose infusion rate curve(AUCGIR).0-12h
Time Frame: 0-12 hours
Area under the glucose infusion rate curve
PD endpoints:maximum glucose infusion rate(GIRmax)
Time Frame: 0-12 hours
maximum glucose infusion rate
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.
PK endpoints: Maximum observed insulin concentration(Cins.max)
Time Frame: 0-12 hours
Maximum observed insulin concentration
Secondary Outcomes
- PK endpoint- time(t)50%-ins(late)(0-12 hours)
- PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-2h(0 to 2 hours)
- PK endpoint- Area under the insulin concentration curve(AUCins).0-2h(0 to 2 hours)
- PK endpoint- Area under the insulin concentration curve(AUCins).0-6h(0 to 6 hours)
- PK endpoint- Area under the insulin concentration curve(AUCins).0-infinity(0 hours to 24 hours)
- PD endpoint: area under the glucose infusion rate curve(AUCGIR).6-12h(6 to 12 hours)
- PK endpoint- Area under the insulin concentration curve(AUCins).6-12h(6 to 12 hours)
- PK endpoint- time(t)50%-ins(early)(0-12 hours)
- PK endpoint- terminal elimination half-life (t½)(0-12 hours)
- PD endpoint: time to maximum glucose infusion rate (tGIR.max)(0-12 hours)
- PD endpoint: time to half-maximum glucose infusion rate before GIRmax (tGIR,50%-early(0-12 hours)
- PK endpoint- time to maximum concentration( tmax)(0-12 hours)
- PK endpoint- terminal elimination rate constant (λz)(0-12 hours)
- PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-6h(0 to 6 hours)
- PD endpoint:time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late)(0-12 hours)
- PD endpoint: Onset of action(0-12 hours)