Bio-availability study of Wosulin® 30/70

Phase 1

Completed

• Registration Number: CTRI/2020/06/026146
• Lead Sponsor: Wockhardt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-03
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

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

2.Subjects having clinically acceptable 12-lead

electrocardiogram (ECG).

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

4. 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.

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

Exclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
PK:AUC0-24and Cmax <br/ ><br>PD:AUCGIR,0-24,and GIRmaxTimepoint: 24hr

Secondary Outcome Measures

Name	Time	Method
AEs, hematology, biochemistry, urinalysis, <br/ ><br>physical examination, vital signs, ECGs, blood glucose level and local tolerabilityTimepoint: 2 â?? 10 weeks from screening to follow up;PK endpoints: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h, <br/ ><br>AUC12-24h, AUC0-ï?¥, tmax, t½ and terminal serum insulin elimination <br/ ><br>half-life <br/ ><br>PD endpoints: AUCGIR,0-4h, AUCGIR,0-6h, AUCGIR,0-12h, AUCGIR,6-12h, <br/ ><br>AUCGIR,6-24h, AUCGIR,12-24h and tGIRmaxTimepoint: 24 hr