CTRI/2023/02/050076已完成1 期
A Randomized, Single Center, Double Blind, Two-Period,Crossover Glucose Clamp Study to Test for Bioequivalencebetween Two Recombinant Human Insulin Analogues -Wockhardt’s Biphasic Insulin Aspart Injection (30/70) andNovomix® 30, in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To test for bioequivalence based on the pharmacokinetic
研究概览
简要总结
The study objective is to test for bioequivalence based on pharmacokinetic and pharmacodynamic parameters of two Recombinant Human Insulin Analogues - Wockhardt’s Biphasic Insulin Aspart Injection (30/70) and NovoMix® 30 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •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.
排除标准
- •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%.
结局指标
主要结局
To test for bioequivalence based on the pharmacokinetic
时间窗: 0-24 hrs
parameters (Cmax and AUC0-24h) of two Recombinant Human
时间窗: 0-24 hrs
Insulin Analogues - Wockhardt’s Biphasic Insulin Aspart Injection (30/70) and NovoMix® 30 in healthy adult male subjects.
时间窗: 0-24 hrs
次要结局
- To test for bioequivalence based on the pharmacodynamic(parameters (AUCGIR,0-24h, and GIRmax) of two Recombinant)
- To compare the pharmacokinetic and pharmacodynamic profile as(well as assess safety and local tolerability of the two Recombinant Human Insulin Analogues.)
研究者
研究点 (1)
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