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临床试验/IRCT20220209053979N2
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

发起方
Alborz Darou

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