study to understand bio availability wockhardtâ??s wosulin® 30/70 and actraphane 30 , in healthysubjects
- Registration Number
- CTRI/2020/04/024787
- Lead Sponsor
- Wockhardt Bio AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects weight within the normal range according to normal
values for the Body Mass Index with minimum of 50 kg weight.
3. Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the
clinically acceptable normal range.
4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
5. Subjects having clinically acceptable chest X-Ray (PA view).
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. Any treatment which could bring about induction or inhibition
of hepatic microsomal enzyme system within 1 month of the study drug administration.
4. 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 <br/ ><br>pharmacokinetic parameters (Cmax and AUC0-24h) of two Biphasic <br/ ><br>Isophane Insulin Injections, Wosulin® 30/70 and Actraphane 30 in <br/ ><br>healthy adult male subjects.Timepoint: 0-24hr
- Secondary Outcome Measures
Name Time Method The secondary objectives are to compare the pharmacokinetic and <br/ ><br>pharmacodynamic profile as well as assess safety and local <br/ ><br>tolerability of the two Biphasic Isophane Insulin Injections.Timepoint: 0-24hrs