A bioequivalence study of DS-5565 (mirogabalin besilate) OD tablet
Phase 1
Completed
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT1080225061
- Lead Sponsor
- DAIICHI SANKYO Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 72
Inclusion Criteria
1) Japanese male
2) Aged 20 years to 45 years (inclusive), at the time of informed consent
3) Body mass index (BMI; calculated by body weight [kg]/height [m]2) in the range of >= 18.5 kg/m2 and < 25.0 kg/m2 at the screening examination
Exclusion Criteria
1) Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy)
2) Presence or history of any drug abuse or of alcohol abuse etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method