CTRI/2019/07/020383尚未招募1 期
A Pilot Study To Compare Bioavailability Between BiphasicIsophane Insulin Injections Wockhardtâ??s Wosulin® 30/70 AndActraphane 30, In Healthy Male Subjects
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 (18.50 to 27.00 kg/m2, both
- •inclusive) with minimum of 50 kg weight.
- •2. Subjects with normal health as determined by medical history,clinical examination and laboratory examinations within the
- •clinically acceptable normal range.
- •3.Subjects having clinically acceptable 12-lead
- •electrocardiogram (ECG).
- •4. Subjects having clinically acceptable chest X-Ray (PA view).
排除标准
- •1. Hypersensitivity to Insulin or related class of drugs.
- •2.Subjects with hemoglobin levels <12.00 gm/dl at screening
- •3.History or presence of significant alcoholism or drug abuse in the past one year.
- •4. HbA1c values (at screening) >= 5.7%
研究者
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