Drug-drug interaction study of K-237 (digoxin, rosuvastatin)
- Conditions
- COVID-19
- Registration Number
- JPRN-jRCT2051220054
- Lead Sponsor
- Tanigawa Ryohei
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 18
(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.
(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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method