NL-OMON45870已完成不适用
A single-center, randomized, double-blind, two-period cross-over study to investigate the effect of rifampicin on the pharmacokinetics of clazosentan in healthy male subjects. - CS0296 (ID-054-106)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
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 65 years (inclusive) with a Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening. ;Further inclusion criteria can be found in the protocol section 3.2.2.
排除标准
- •1. Previous exposure to clazosentan.
- •2. Previous exposure to rifampicin within 3 months prior to Screening.
- •3. Known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients. ;Further exclusion criteria can be found in the protocol section 3.2.3.
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