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 injectionsWockhardtâ??s wosulin® 30/70 and actraphane 30 , in healthySubjects - W-WOS(M)-106
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
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.
- •3. Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the
- •clinically acceptable normal range.
- •4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- •5. Subjects having clinically acceptable chest X-Ray (PA view).
排除标准
- •1.Hypersensitivity to Insulin or related class of drugs.
- •2. History or presence of significant cardiovascular, pulmonary,hepatic, renal, gastrointestinal, endocrine, immunological,
- •dermatological, neurological or psychiatric disease or disorder.
- •3. Any treatment which could bring about induction or inhibition
- •of hepatic microsomal enzyme system within 1 month of the study drug administration.
- •4. History or presence of significant alcoholism or drug abuse in the past one year.
研究者
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