Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R
- Conditions
- Healthy Volunteer
- Interventions
- Biological: Humulin®RBiological: Biocon Insulin R
- Registration Number
- NCT04022317
- Lead Sponsor
- Biocon Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Humulin® R (regular insulin human) Humulin®R 0.3 IU/kg Dose per administration, subcutaneous Route of administration Biocon Insulin R Biocon Insulin R 0.3 IU/kg Dose per administration, subcutaneous Route of administration
- Primary Outcome Measures
Name Time Method PD endpoints: Area under the glucose infusion rate curve(AUCGIR).0-12h 0-12 hours Area under the glucose infusion rate curve
PD endpoints:maximum glucose infusion rate(GIRmax) 0-12 hours maximum glucose infusion rate
PK endpoints:Area under the insulin concentration curve(AUCins).0-12h 0-12 hours Area under the insulin concentration curve from 0 to 12 hours.
PK endpoints: Maximum observed insulin concentration(Cins.max) 0-12 hours Maximum observed insulin concentration
- Secondary Outcome Measures
Name Time Method PK endpoint- time(t)50%-ins(late) 0-12 hours time to half-maximum after Cins.max.
PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-2h 0 to 2 hours area under the glucose infusion rate curve
PK endpoint- Area under the insulin concentration curve(AUCins).0-2h 0 to 2 hours Area under the insulin concentration curve
PK endpoint- Area under the insulin concentration curve(AUCins).0-6h 0 to 6 hours area under the insulin concentration curve
PK endpoint- Area under the insulin concentration curve(AUCins).0-infinity 0 hours to 24 hours area under the insulin concentration-time curve
PD endpoint: area under the glucose infusion rate curve(AUCGIR).6-12h 6 to 12 hours area under the glucose infusion rate curve
PK endpoint- Area under the insulin concentration curve(AUCins).6-12h 6 to 12 hours area under the insulin concentration curve
PK endpoint- time(t)50%-ins(early) 0-12 hours time to half-maximum before Cins.max.
PK endpoint- terminal elimination half-life (t½) 0-12 hours terminal elimination half-life calculated as t½=ln2/λz.
PD endpoint: time to maximum glucose infusion rate (tGIR.max) 0-12 hours time to maximum glucose infusion rate
PD endpoint: time to half-maximum glucose infusion rate before GIRmax (tGIR,50%-early 0-12 hours time to half-maximum glucose infusion rate before GIRmax
PK endpoint- time to maximum concentration( tmax) 0-12 hours time to maximum observed insulin concentration.
PK endpoint- terminal elimination rate constant (λz) 0-12 hours terminal elimination rate constant of insulin.
PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-6h 0 to 6 hours area under the glucose infusion rate curve
PD endpoint:time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late) 0-12 hours time to half-maximum glucose infusion rate after Maximum glucose infusion rate(GIRmax)
PD endpoint: Onset of action 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)
Trial Locations
- Locations (1)
Profil Mainz GmbH
🇩🇪Mainz, Germany