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

Biocon Limited42 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteer

Interventions

Biocon Insulin RBIOLOGICAL

Biocon Insulin R is a short-acting human insulin, produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing Pichia pastoris (yeast).

Humulin®RBIOLOGICAL

Humulin® R is a polypeptide hormone structurally identical to human insulin synthesised through recombinant deoxyribonucleic acid (rDNA) technology in a non-pathogenic laboratory strain of Escherichia coli bacteria.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Profil Mainz GmbH

Mainz, Germany

Outcomes

Primary Outcomes

PK endpoints:Area under the insulin concentration curve(AUCins).0-12h

Area under the insulin concentration curve from 0 to 12 hours.

Time frame: 0-12 hours

PD endpoints: Area under the glucose infusion rate curve(AUCGIR).0-12h

Area under the glucose infusion rate curve

Time frame: 0-12 hours

PK endpoints: Maximum observed insulin concentration(Cins.max)

Maximum observed insulin concentration

Time frame: 0-12 hours

PD endpoints:maximum glucose infusion rate(GIRmax)

maximum glucose infusion rate

Time frame: 0-12 hours

Secondary Outcomes

PK endpoint- Area under the insulin concentration curve(AUCins).0-2h

Area under the insulin concentration curve

Time frame: 0 to 2 hours

PK endpoint- Area under the insulin concentration curve(AUCins).0-6h

area under the insulin concentration curve

Time frame: 0 to 6 hours

PK endpoint- Area under the insulin concentration curve(AUCins).6-12h

area under the insulin concentration curve

Time frame: 6 to 12 hours

PK endpoint- Area under the insulin concentration curve(AUCins).0-infinity

area under the insulin concentration-time curve

Time frame: 0 hours to 24 hours

Data from ClinicalTrials.gov

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