CTRI/2020/06/026146已完成1 期
A Pilot Study To Compare Bioavailability Between BiphasicIsophane Insulin Injections Wockhardtâ??s Wosulin® 30/70 AndHumulinï?? 70/30, In Healthy Male Subjects
Wockhardt Ltd0 个研究点目标入组 14 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
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 with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
- •2.Subjects having clinically acceptable 12-lead
- •electrocardiogram (ECG).
- •3.Subjects having clinically acceptable chest X-Ray (PA view)
- •4. Subjects weight within the normal range according to normal values for the Body Mass Index (18.50 to 27.00 kg/m2, both inclusive) with minimum of 50 kg weight.
- •5.Non-smoker, defined as no nicotine consumption for last six months.
排除标准
- •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
- •3. Subjects with hemoglobin levels <12.00 gm/dl at screening or
- •hemoglobinopathy will not be eligible for the study
- •4. Any treatment which could bring about induction or inhibition
- •of hepatic microsomal enzyme system within 1 month of the
- •study drug administration
- •5. History or presence of significant alcoholism or drug abuse in
- •the past one year.
- •6. HbA1c values (at screening) >= 5.7%
研究者
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