A Randomized, Single Center, Double Blind, Two-Period,Crossover Glucose Clamp Study to Test for Bioequivalencebetween Two Recombinant Human Insulin Analogues -Wockhardtâ??s Biphasic Insulin Aspart Injection (30/70) andNovomixÂ® 30, in Healthy Subjects - W-ASP (B)-103

Wockhardt Bio AG0 个研究点目标入组 56 人开始时间: 待定最近更新: 2023年6月26日

试验速览

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•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 (ECG).
•Subjects having clinically acceptable chest X-Ray (PA view).
•Non-smoker, defined as no nicotine/tobacco consumption for last six months.

•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 starting.
•History or presence of alcoholism or drug abuse
•HbA1c values (at screening) >= 5.7%.

发起方