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临床试验/IRCT20200407046981N1
IRCT20200407046981N1尚未招募未知

Randomized, single-dose, crossover comparative bioequivalence study of Teriflunomide (Trigio®) 14 mg tablets produced by Zahravi Pharmaceutical Co. versus Aubagio® tablets of Sanofi Genzyme Co. in 14 healthy male under fasting conditions

Zahravi pharmaceutical company0 个研究点目标入组 14 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
入组人数
14

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
16 years 至 60 years(—)
性别
Male

入选标准

  • Healthy subjects with BMI 18.5-30 kg/m2
  • Not having any abnormal finding in laboratory examination or during physical examination.
  • Not having a history of any significant disease.
  • 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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