CTRI/2020/04/024787尚未招募1 期
A randomized, single center, double blind, two treatment,Two-period, crossover glucose clamp study to test forBioequivalence between biphasic isophane insulin injectionsWockhardt’s wosulin® 30/70 and actraphane 30 , in healthySubjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary objective is to test for bioequivalence based on the
研究概览
简要总结
The study objective is to test for bioequivalence based on
pharmacokinetic and pharmacodynamic parameters of two
Biphasic Isophane Insulin Injections, Wosulin® 30/70 and
Actraphane 30 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block 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
- •1.Subjects weight within the normal range according to normal values for the Body Mass Index 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).
排除标准
- •1.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.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study drug administration.
- •History or presence of significant alcoholism or drug abuse in the past one year.
结局指标
主要结局
The primary objective is to test for bioequivalence based on the
时间窗: 0-24hr
pharmacokinetic parameters (Cmax and AUC0-24h) of two Biphasic
时间窗: 0-24hr
Isophane Insulin Injections, Wosulin® 30/70 and Actraphane 30 in
时间窗: 0-24hr
healthy adult male subjects.
时间窗: 0-24hr
次要结局
- The secondary objectives are to compare the pharmacokinetic and(pharmacodynamic profile as well as assess safety and local)
研究者
研究点 (1)
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