Bio-equivalence study of Biphasic Insulin Aspart Injection (30/70)

Phase 1

Completed

• Conditions: To test comparative efficacy of drugs used in diabetes mellitus

• Registration Number: CTRI/2023/02/050076
• Lead Sponsor: Wockhardt Bio AG

Brief Summary

The study objective is to test for bioequivalence based on pharmacokinetic and pharmacodynamic parameters of two Recombinant Human Insulin Analogues - Wockhardt’s Biphasic Insulin Aspart Injection (30/70) and NovoMix® 30 in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-27
• Study Completion: 2023-06-14
• Last Update Posted: 2023-06-19

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 56

Inclusion Criteria

• Subjects weight within the normal range according to normal values for the Body Mass Index (18.5 to 27.0 -kg/m2, inclusive) with minimum of 50 kg weight.
• Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
• Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
• Subjects having clinically acceptable chest X-Ray (PA view).
• Non-smoker, defined as no nicotine/tobacco consumption for last six months.

Exclusion Criteria

• Hypersensitivity to Insulin or related class of drugs.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
• Subjects with hemoglobin levels <12.5 gm/dl at screening or hemoglobinopathy.
• Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
• History or presence of alcoholism or drug abuse HbA1c values (at screening) ≥ 5.7%.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To test for bioequivalence based on the pharmacokinetic	0-24 hrs
parameters (Cmax and AUC0-24h) of two Recombinant Human	0-24 hrs
Insulin Analogues - Wockhardt’s Biphasic Insulin Aspart Injection (30/70) and NovoMix® 30 in healthy adult male subjects.	0-24 hrs

Secondary Outcome Measures

Name	Time	Method
To test for bioequivalence based on the pharmacodynamic	parameters (AUCGIR,0-24h, and GIRmax) of two Recombinant
To compare the pharmacokinetic and pharmacodynamic profile as	well as assess safety and local tolerability of the two Recombinant Human Insulin Analogues.

Trial Locations

Locations (1)

Research and Development Centre - Wockhardt Limited; 🇮🇳 Aurangabad, MAHARASHTRA, India

Research and Development Centre - Wockhardt Limited

🇮🇳Aurangabad, MAHARASHTRA, India

Dr Nilesh Lomte

Principal investigator

02406651600

enileshlomte@gmail.com