NL-OMON37306已完成不适用
A single-center, open-label, randomized, two-period, two-treatment, crossover study in healthy male subjects to demonstrate bioequivalence of 1600 mcg selexipag administered as eight tablets of 200 mcg (reference drug) or as single tablet of 1600 mcg (test drug) - Selexipag / ACT-293987 bioequivalence study
Actelion Pharmaceuticals0 个研究点目标入组 124 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
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 至 99（—）
入选标准
- •Healthy male subjects aged between 18 and 55 years (inclusive)
- •No clinically significant findings at Screening.
- •Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- •Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate (PR) 45-90 bpm (inclusive);Refer to protocol for complete list of inclusion criteria
排除标准
- •Known allergic reactions or hypersensitivity to selexipag
- •History or clinical evidence of any clinical significant disease and/or existence of any surgical or medical condition.
- •History or clinical evidence of alcoholism or drug abuse
- •Excessive caffeine consumption;Refer to protocol for a complete list of exclusion criteria
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