DS-5058b (extended-release tablet) bioequivalence study
Phase 1
Completed
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT1080223420
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
The ratio of geometric least-square means and 90% CI for Cmax and AUCt were within the bioequivalence criteria (0.80-1.25) under both fasting and fed conditions. Therefore, DS-5058b (extended-release tablet) was judged to be bioequivalent to the reference drug. There was no meaningful difference in TEAE between 10 mg DS-5058b (extended-release tablet) and reference drug under both fasting and fed conditions, and no safety concern was noted in single oral administration of both drugs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 48
Inclusion Criteria
Male Japanese
- Between the age of 20 and 45
- Between the BMI of 18.5 and 24.9
Exclusion Criteria
- Presence or history of hypersensitivity or idiosyncratic reaction (penicillin allergy etc.) to a drug.
- Presence or history of drug or alcohol dependence, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>Pharmacokinetics
- Secondary Outcome Measures
Name Time Method safety<br>Safety