Clinical Pharmacology Study of CS-3150 Drug-drug interaction study between CS-3150 and amlodipine in healthy Japanese subjects
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080223324
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
In study 1, the pharmacokinetics of esaxerenone was not affected by amlodipine when esaxerenone 2.5 mg was coadministered with amlodipine 10 mg. In study 2, AUC for amlodipine was increased by approximately 1.2 fold, but Cmax for amlodipine was not increased when amlodipine 2.5 mg was coadministered with esaxerenone 5 mg. It was considered that there were no safety concerns when esaxerenone was administered concomitantly with amlodipine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 44
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