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临床试验/CTRI/2020/04/024787
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

Wockhardt Bio AG0 个研究点目标入组 0 人开始时间: 待定最近更新:

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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