JPRN-jRCT2051210203已完成1 期
Drug-drug interaction study to assess the effects of administration of clarithromycin or rifampicin on the pharmacokinetics of K-237 in healthy adult volunteers
Tanigawa Ryohei0 个研究点目标入组 30 人开始时间: 2022年3月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
Cmax and AUC0-72h of K-237 increased when K-237 was co-administered with clarithromycin, while these parameters decreased when K-237 was administered following repeated dosing of rifampicin, suggesting that K-237 may be affected by drug interactions with clarithromycin or rifampicin. Finally, no safety issues were identified in the treatment periods.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 45age old（—）
- 性别
- Male
入选标准
- •(1) Subject is a healthy adult male volunteer.
- •(2) Subject is between the ages of 18 and 45 years at the time of signing informed consent.
- •(3) Subject has a body mass index of 17.6 to 26.4 kg/m2 at Screening.
排除标准
- •(1) Subject has used a drug (including over-the-counter drug, vaccination) within 14 days before the administration of the study drug in the first treatment period, or those who need to use it during the study period.
- •(2) Subject has received products containing St John's wort within 4 weeks before the administration of the study drug in the first treatment period. Subject has received supplements and products containing grapefruit within 14 days before the administration of the study drug in the first treatment period.
- •(3) Subject has a current malabsorption, and those who had an operation on the gastrointestinal tract that may affect absorption (excluding appendectomy).
研究者
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