IRCT20200407046981N46尚未招募未知
Comparative bioequivalence study of the Sertraline 100-mg Tablets manufactured by Modava Company with Sertraline brand tablets (Zoloft®) produced by Pfizer company
Modava Pharmaceutical Company0 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
- 尚未招募
- 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
- Interventional
入排标准
- 年龄范围
- 18 years 至 60 years（—）
- 性别
- Male
入选标准
- •Healthy male volunteers in the age range of 18-60 years old
- •The weight limit of each volunteer should be between 60 and 100 kg.
- •Body mass index should be between18-30
- •All volunteers must be non-smokers
- •They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed
- •Candidates who have consented to the consent form
排除标准
- •Known hypersensitivity or idiosyncratic reaction to Sertralin or any ingredients.
- •Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg.
- •Taking any medicine during two week before dosing.
- •Any effects of renal, hepatic, cardiac, pulmonary or gastrointestinal dysfunction
- •Any history of tuberculosis, seizures, asthma, diabetes, insanity or glaucoma
研究者
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