A Bioequivalence study of DS-5058b (immediate-release tablet) and oxycodone hydrochloride hydrate in healthy Japanese subjects
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Registration Number
- JPRN-jRCT1080223737
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
The ratio of geometric least-square means and 90% CI for Cmax and AUCall were within the bioequivalence criteria (0.80-1.25). DS-5058b (immediate-release tablet) was judged to be bioequivalent to the reference drug. - There was no meaningful difference in TEAE between 5 mg DS-5058b (immediate-release tablet) and reference drug, 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
- 31
Inclusion Criteria
Japanese male
- Between the age of 20 and 45
- 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
Exclusion Criteria
- Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy)
- People with drug or alcohol dependence. etc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method