BA-BE study for WOCKHARDTâ??SWOSULIN® N AND HUMULIN

Phase 1

Completed

• Registration Number: CTRI/2020/06/026261
• Lead Sponsor: Wockhardt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-08-24
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

1.Subjects weight within the normal range according to normal values for the Body Mass Index (18.50 to 27.00 kg/m2, both inclusive) with minimum of 50 kg weight.

2.Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.

3.Subjects having clinically acceptable 12-lead electrocardiogram (ECG).

4.Subjects having clinically acceptable chest X-Ray (PA view).

5.Non-smoker, defined as no nicotine consumption for last six months

Exclusion Criteria

1.Hypersensitivity to Insulin or related class of drugs.

2.History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.

3.Subjects with hemoglobin levels <12.00 gm/dl at screening or hemoglobinopathy will not be eligible for the study

4.Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study drug administration

5.History or presence of significant alcoholism or drug abuse in the past one year.

6.HbA1c values (at screening) >=5.7%

Study & Design

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