CTRI/2021/09/036601
Completed
未知
A Randomized, Single Center, Double Blind, Two-Period, CrossoverGlucose Clamp Study to test for bioequivalence between twoRecombinant Human Insulin Analogues - Wockhardtâ??s BiphasicInsulin Aspart Injection (30/70) and NovoMix® 30, in HealthySubjects
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Wockhardt Bio AG
- Enrollment
- 14
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects weight within the normal range according to normal
- •values for the Body Mass Index (18\.5 to 27\.0 kg/m2, inclusive)
- •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
- •Subjects having clinically acceptable chest X\-Ray (PA view).
- •Non\-smoker, defined as no nicotine/tobacco consumption for last
- •six months.
Exclusion Criteria
- •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.
- •Subjects with hemoglobin levels \<12\.5 gm/dl at screening or hemoglobinopathy.
- •Any treatment which could bring about induction or inhibition of
- •hepatic microsomal enzyme system within 1 month of the study
- •History or presence of alcoholism or drug abuse in the past one year.
- •HbA1c values (at screening) \>\= 5\.7%.
Outcomes
Primary Outcomes
Not specified
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