IRCT20220209053979N2已完成未知
A cross over bioequivalence study of losartan H 50/12.5 mg tablet compared to Hyzaar 50/12.5 mg tablet manufactured by Merck in 24 healthy volunteers under fasting condition
Alborz Darou0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 years 至 55 years(—)
- 性别
- All
入选标准
- •Sex: male.Age: 18 - 55 years. . BMI of 18-27 kg/m2 with minimum of 50 kg weight.
- •Volunteer willing to adhere to the protocol requirements and to provide written informed consent
- •Non-smokers or smoker who smokes less than 10 cigarettes per day
排除标准
- •Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- •Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- •Pulse rate less than 50/minute or more than 100/minute.
- •History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- •History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study
研究者
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