DRKS00004349进行中（未招募）1 期
A single-center, randomized, open-label cross-over study to investigate the drug-drug interaction of trimethoprim and metformin in healthy volunteers - KPE22
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Healthy male or female
- •- No clinically relevant findings at screening
- •- body mass index between 18 and 30 kg/m²
- •- willing to use contraceptive measures
排除标准
- •- Clinically relevant deviation of laboratory parameters at screening
- •- Pathologic deviations in the hemogram at screening
- •- Fasted plasma glucose of 100 mg/dl or higher at screening
- •- Anamnestically known glucose malabsorption
- •- Simultaneous participation in another clinical study according to the German Drug Law
- •- Use of other medication within 14 days before study start (except for hormonal contraceptives)
- •- smoking of 5 or more cigarettes per day
- •- Dependency of alcohol, illegal drugs or medication
- •- Current, relevant disease or relevant physiologic change
- •- Blood loss of 200 ml blood or more within 4 weeks before study start
- •- Contraindication for the use of one of the investigational drugs
- •- Pregnancy or lactation
- •- No capacity to consent
- •- dependence on one of the investigators
研究者
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