Bio-availability trial of Wosulin® 30/70

Phase 1

• Registration Number: CTRI/2019/07/020383
• Lead Sponsor: Wockhardt Bio AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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).

Exclusion Criteria

1. Hypersensitivity to Insulin or related class of drugs.

2.Subjects with hemoglobin levels <12.00 gm/dl at screening

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

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

Study & Design

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