A Randomized, Single Centre, Double Blind Three Treatment Three Period, Crossover Glucose Clamp Study to Test for Bioequivalence between Recombinant Human Insulins, Wockhardt’sWosulin Regular Insuln Human (E. Coli) with Wockhardt’s Wosulin Regular Insulin Human (Yeast) and Bioequivalence between Wockhardt’s Wosulin Regular Insulin Human (E.Coli) with Humulin® R, in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary objective is to test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-12h) and pharmacodynamic parameters (AUCGIR0-12h, and GIRmax) between recombinant human insulin formulations in healthy subjects as follows:
研究概览
简要总结
The study is still in start up phase
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •Male subjects aged between 18 and 45 years both inclusive Subjects weight within the normal range according to normal values for the Body Mass Index -18.50 to 27.00 kg/m2, inclusive with minimum of 50 kg weight Subjects without any evidence of impaired glucose tolerance in 2 hour OGTT.
- •Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
排除标准
- •Hypersensitivity to Insulin or related class of drugs.
- •Subjects with hemoglobin levels 12.15 gm/dl at screening or hemoglobinopathy will not be eligible for the study Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
结局指标
主要结局
The primary objective is to test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-12h) and pharmacodynamic parameters (AUCGIR0-12h, and GIRmax) between recombinant human insulin formulations in healthy subjects as follows:
时间窗: The primary objective is to test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-12h) and pharmacodynamic parameters (AUCGIR0-12h, and GIRmax) between recombinant human insulin formulations in healthy subjects as follows: | •Wockhardt’s Regular Insulin Human (Yeast) and Wockhardt’s Regular Insulin Human (E.Coli) | •Wockhardt’s Regular Insulin Human (E.Coli) and HUMULIN® R
•Wockhardt’s Regular Insulin Human (Yeast) and Wockhardt’s Regular Insulin Human (E.Coli)
时间窗: The primary objective is to test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-12h) and pharmacodynamic parameters (AUCGIR0-12h, and GIRmax) between recombinant human insulin formulations in healthy subjects as follows: | •Wockhardt’s Regular Insulin Human (Yeast) and Wockhardt’s Regular Insulin Human (E.Coli) | •Wockhardt’s Regular Insulin Human (E.Coli) and HUMULIN® R
•Wockhardt’s Regular Insulin Human (E.Coli) and HUMULIN® R
时间窗: The primary objective is to test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-12h) and pharmacodynamic parameters (AUCGIR0-12h, and GIRmax) between recombinant human insulin formulations in healthy subjects as follows: | •Wockhardt’s Regular Insulin Human (Yeast) and Wockhardt’s Regular Insulin Human (E.Coli) | •Wockhardt’s Regular Insulin Human (E.Coli) and HUMULIN® R
次要结局
- The secondary objectives are to compare the pharmacokinetic and pharmacodynamic profile as well as assessing safety and local tolerability of the three insulin preparations.(during the 3 clamp)