Drug-drug interaction study to assess the effects of administration of K-237 on the pharmacokinetics of digoxin or rosuvastatin in healthy adult volunteers (COVID-19)

Tanigawa Ryohei0 个研究点目标入组 18 人开始时间: 2022年6月18日最近更新: 2023年10月17日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 18

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

In K-237-05, the drug interaction of K-237 affecting PK of digoxin and rosuvastatin was confirmed by comparing the plasma PK parameters for unchanged digoxin and unchanged rosuvastatin of a single oral dose of digoxin and rosuvastatin, and a 3-day repeated dose of K-237 followed by a single oral dose of digoxin and rosuvastatin, in healthy adult male subjects. In addition, the safety of the treatment periods was also examined.

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

发起方

Tanigawa Ryohei

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