CTRI/2023/02/049975招募中未知
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Gliclid 60 mg MR tablet (Gliclazide 60 mg MR tablet) of The ACME Laboratories Ltd., in comparison with Diamicronï?¢ 60 mg MR tablet (Gliclazide 60 mg MR tablet) of Les Laboratories Servier Industrie in healthy, adult, human subjects under fasting condition. - NI
试验速览
- 阶段
- 未知
- 状态
- 招募中
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 Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study
- •2 Willing to be available for the entire study period and to comply with protocol requirements.
- •3 Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
- •4 Body mass index in the range of 18 â?? 30 kg/m2 (both inclusive).
排除标准
- •Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs.
- •History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
- •History of severe infection or major surgery in the past 6 months.
- •History of Minor surgery or fracture within the past 3 months.
研究者
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