study to understand bio availability wockhardt’s wosulin® 30/70 and actraphane 30 , in healthysubjects

Phase 1

Not yet recruiting

• Conditions: assessing bio-availability of test drug

• Registration Number: CTRI/2020/04/024787
• Lead Sponsor: Wockhardt Bio AG

Brief Summary

The study objective is to test for bioequivalence based on

pharmacokinetic and pharmacodynamic parameters of two

Biphasic Isophane Insulin Injections, Wosulin® 30/70 and

Actraphane 30 in healthy subjects.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-04-22
• Study Start: 2020-04-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• 1.Subjects weight within the normal range according to normal values for the Body Mass Index 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).

Exclusion Criteria

• 1.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.
• Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study drug administration.
• History or presence of significant alcoholism or drug abuse in the past one year.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
The primary objective is to test for bioequivalence based on the	0-24hr
pharmacokinetic parameters (Cmax and AUC0-24h) of two Biphasic	0-24hr
Isophane Insulin Injections, Wosulin® 30/70 and Actraphane 30 in	0-24hr
healthy adult male subjects.	0-24hr

Secondary Outcome Measures

Name	Time	Method
The secondary objectives are to compare the pharmacokinetic and	pharmacodynamic profile as well as assess safety and local

Trial Locations

Locations (1)

Clinical Pharmacokinetics & Biopharmaceutics Department; 🇮🇳 Aurangabad, MAHARASHTRA, India

Clinical Pharmacokinetics & Biopharmaceutics Department

🇮🇳Aurangabad, MAHARASHTRA, India

Dr Nilesh Lomte

Principal investigator

2406651600

enileshlomte@gmail.com