IRCT20130313012810N5已完成未知
Comparative bioequivalence study of the Dapagliflozin 10-mg tablets manufactured by Noavaran Daroui Kimia Company
KIMIA Noavaran Daroui0 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 60 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 allergic or adverse reaction to dapagliflozin or any similar product.
- •Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg.
- •People who 10 days before the first day of consumption, Drug-experienced
- •Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s).
研究者
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