Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R

Biocon

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Biological: Humulin®R

Biological: Biocon Insulin R

Study type

Interventional

Funder types

Industry

Identifiers

NCT04022317

EQR

Details and patient eligibility

About

Single-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover,12-hour euglycaemic glucose clamp trial in healthy subjects

Full 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.

Enrollment

42 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.