Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N
- Conditions
- Healthy Volunteer
- Interventions
- Biological: Biocon Insulin NBiological: Humulin® N
- Registration Number
- NCT04022304
- Lead Sponsor
- Biocon Limited
- Brief Summary
Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects
- Detailed Description
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin N with Humulin® N in healthy subjects.
The treatment consists of one single dose of the test or reference product, administered during each of the three study periods, separated by 5-7 days between each dosing. The planned trial duration for each subject is about 17 to 43 days. Eligible subjects will undergo three euglycaemic clamp examinations (each of 24 hours duration).
Depending on the sequence in which a particular subject is randomized, each subject will either undergo two clamps with administration of test product plus one clamp with administration of reference product, or, two clamps with administration of reference product plus one clamp with administration of test product, in random order.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Healthy male and post-menopausal female subjects. Post-menopausal defined as 12 months of no menses 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 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.
- 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.
- Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sequence: Biocon Insulin N- Humulin® N- Humulin® N Biocon Insulin N Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Humulin® N(100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days Sequence: Biocon Insulin N- Biocon Insulin N-Humulin® N Biocon Insulin N Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days Sequence: Humulin® N- Humulin® N-Biocon Insulin N Biocon Insulin N Period 1: 0.4 IU/kg of Humulin® N(100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days Sequence: Biocon Insulin N- Humulin® N- Biocon Insulin N Humulin® N Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days Sequence: Humulin® N-Biocon Insulin N- Biocon Insulin N Humulin® N Period 1: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days Sequence: Humulin® N- Biocon Insulin N-Humulin® N Biocon Insulin N Period 1: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days Sequence: Biocon Insulin N- Humulin® N- Humulin® N Humulin® N Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Humulin® N(100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days Sequence: Humulin® N- Humulin® N-Biocon Insulin N Humulin® N Period 1: 0.4 IU/kg of Humulin® N(100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days Sequence: Biocon Insulin N- Humulin® N- Biocon Insulin N Biocon Insulin N Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days Sequence: Humulin® N-Biocon Insulin N- Biocon Insulin N Biocon Insulin N Period 1: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days Sequence: Humulin® N- Biocon Insulin N-Humulin® N Humulin® N Period 1: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days Sequence: Biocon Insulin N- Biocon Insulin N-Humulin® N Humulin® N Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days
- Primary Outcome Measures
Name Time Method Primary PK endpoint: maximum observed insulin concentration(Cins.max) 0-24hour maximum observed insulin concentration
Primary PK endpoint: area under the insulin concentration curve(AUCins).0-24h 0-24hour area under the insulin concentration curve
PD endpoint:area under the glucose infusion rate curve(AUCGIR)0-24h 0-24hour area under the glucose infusion rate curve
PD endpoint:maximum observed glucose infusion rate (GIRmax) 0-24hour maximum observed glucose infusion rate
- Secondary Outcome Measures
Name Time Method Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).12-24h 12-24hour area under the insulin concentration-time curve
Secondary PK endpoint: time(t)50%-INS(late) 0-24 hours time to half-maximum after Cmax
Secondary PD endpoint: Onset of action 0-24 hours time 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))
Secondary PK endpoint: terminal elimination half-life (t½) 0-24 hours terminal elimination half-life calculated as t½=ln2/λz
Secondary PK endpoint: time(t)50%-INS(early) 0-24 hours time to half-maximum before Cmax
Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h 12-24hours areas under the glucose infusion rate curve
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-infinity 0-24 hours area under the insulin concentration-time curve
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-12h 0-12hour area under the insulin concentration-time curve
Secondary PK endpoint:time to maximum observed insulin concentration (tmax.ins) 0-24 hours time to maximum observed insulin concentration
Secondary PD endpoint: time to maximum glucose infusion rate(tmax.GIR) 0-24 hours time to maximum glucose infusion rate
Secondary PD endpoint:time to half-maximum glucose infusion rate before GIRmax (tGIR.50%-early) 0-24 hours time to half-maximum glucose infusion rate before GIRmax
Secondary PD endpoint: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late) 0-24 hours time to half-maximum glucose infusion rate after GIRmax
Secondary PK endpoint:terminal elimination rate constant of insulin (λz) 0-24 hours terminal elimination rate constant of insulin
Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).0-12h 0-12hours areas under the glucose infusion rate curve
Trial Locations
- Locations (1)
Profil Institut für Stoffwechselforschung GmbH
🇩🇪Neuss, Germany