EUCTR2011-001893-24-DE进行中（未招募）不适用
Relative bioavailability and food effect study of two oral liquid formulations in comparison to a 1mg tablet of riociguat to characterize its pharmacokinetic properties in healthy male and female adult subjects in a randomized, open label, 5 fold crossover design
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Healthy male or female volunteers, age 18-45 years, BMI 18.0-29.9 kg/m², SBP 110-145 mmHg, no drugs 2 weeks before treatment, non-smokers for at least 12 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- •Medical disorder that would impair the subject’s ability to complete the study in the opinion of the Investigator
- •Known hypersensitivity to the study drugs (active substance or excipients of the preparations)
- •Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- •Relevant diseases within the last 4 weeks prior to the first study drug administration
- •Regular use of medicines
- •Regular use of therapeutic or recreational drugs
- •Use of any medication within the 2 weeks preceding the study
研究者
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