Clinical Pharmacology Study of CS-3150 A single dose study to assess the absolute bioavailability and effect of food on the pharmacokinetics of CS-3150 in Japanese healthy subjects
Phase 1
Completed
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080223397
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
Absolute bioavailability of a single oral 5-mg dose of esaxerenone in healthy Japanese subjects was 89.0% in the fasting state and 90.8% in the postprandial state. Food intake does not affect esaxerenone PK. Additionally, no safety concerns were identified.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
1)Japanese male
2)Persons >= 20 years and =< 45 years of age at the time of informed consent
3)Persons with a body mass index (BMI; calculated by body weight [kg]/height [m]2) of >= 18.5 kg/m2 and < 25.0 kg/m2 at the screening examination
Exclusion Criteria
1)Persons with hypersensitivity or idiosyncratic reactions to a drug, (such as penicillin allergy)
2)Persons with drug or alcohol dependence
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method bioavailability<br>pharmacokinetics<br>Pharmacokinetics and safety
- Secondary Outcome Measures
Name Time Method