IRCT20200407046981N26尚未招募未知
Comparative bioequivalence study of Fingolimod 0.5 mg capsules manufactured by Zahravi Pharmaceutical Company versus Gilenya® (Novartis Company)
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 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 55 years（—）
- 性别
- Male
入选标准
- •The weight limit of each volunteer should be between 60 and 100 kg.
- •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 Fingolimod or any ingredients.
- •Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg.
- •Regular smoker who smokes more than ten cigarettes daily.
- •Taking any medicine during two weeks before dosing.
研究者
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