IRCT20180620040164N52已完成Unknown
Bioequivalence study of empagliflozin 12.5 combined tablet with metformin 1000 mg of Daro Darman Pars company in comparison with the reference sample of Syngardi made by Boehringer company.
Darou darman Pars 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
- Unknown
- 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
- 20 years 至 45 years(—)
- 性别
- Male
入选标准
- •Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2.
- •Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
- •Subjects with normal vital signs.
- •Subjects who agree with patient consent form.
排除标准
- •Subjects with known allergy to the products tested.
- •History of diabetes or other endocrine diseases
- •moking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
- •A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.
研究者
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