IRCT20180620040164N2已完成未知
Randomized, single-dose, crossover comparative bioequivalence study of Ondansetron 4 mg film-coated tablets of Aburaihan Pharmaceutical Co. and Zofran 4 mg film-coated tablet of Novartis Co. in 24 healthy male under fasting conditions
Aburaihan pharmaceutical co.0 个研究点目标入组 24 人开始时间: 待定最近更新:
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
- Interventional
入排标准
- 年龄范围
- 18 years 至 45 years（—）
- 性别
- Male
入选标准
- •Healthy subjects with BMI 18.5-30 kg/m2
- •Not having a history of any significant disease.
- •Not having any abnormal finding in laboratory examination or during physical examination.
- •Subjects who agree with patient consent form.
排除标准
- •Known hypersensitivity or idiosyncratic reaction to Ondansetron or any ingredients.
- •Subjects with BP = 9060 mm/Hg or BP = 140/90 mm/Hg
- •Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function or a history of TB, epilepsy, asthma (during past 5 years), DM, psychosis or glaucoma.
- •Regular smoker who smokes more than ten cigarettes daily.
- •Taking any medicine during two week before dosing
研究者
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