IRCT20130313012810N7已完成未知
Comparative bioequivalence study of the Amiodarone 200-mg Tablets manufactured by Behestan Pharmaceutical Company
Behestan Daru Co0 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 50 years（—）
- 性别
- Male
入选标准
- •The weight range of participating candidates must be between 60-100 kg
- •All candidates must be non-smokers
- •The candidates must be healthy in terms of physical examination, ECG and the following laboratory tests: hemoglobin, hematocrit, red and white blood count, MCV ( mean body mass), MCH (mean body hemoglobin), routine urinalysis, total cholesterol, triglycerides, total proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), amino aspartate transferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose
- •Volunteers who agreed to the informed consent form
排除标准
- •History of sensitivity or idiosyncrasy to amiodarone or any of the inactive components of the formulation.
- •Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg.
- •Taking any medication within 2 weeks before receiving the medication.
研究者
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