Clinical Pharmacology Study of CS-3150 Drug-drug interaction Study between CS-3150 and digoxin or rifampicin in healthy Japanese subjects.
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080223388
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
In study 1, digoxin Cmax at steady state was increased by 1.13 fold when digoxin 0.25 mg was coadministered with esaxerenone 5 mg. However, digoxin Ctrough and AUC were not increased. In study 2, esaxerenone Cmax and AUC were decreased by 0.31 fold and 0.66 fold, respectively, when esaxerenone 5 mg was coadministered with rifampicin 600 mg. It was considered that there were no safety concerns when esaxerenone was coadministered with either digoxin or amlodipine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 32
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
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 pharmacokinetics<br>Pharmacokinetics and safety
- Secondary Outcome Measures
Name Time Method