DS-8500a atorvastatin DDI study
Phase 1
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080222826
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
1. Japanese
2. Between the age of 20 and 40
3. Between the BMI of 18.5 and 25.0
4. HbA1c < 6.5%
5. Fasting blood glucose level within the reference range of a site
Exclusion Criteria
1. Presence or history of hypersensitivity or idiosyncratic reaction (penicillin allergy etc,) to a drug including atorvastatin.
2. Presence or history of drug or alcohol dependence. etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The PK parameters of atorvastatin
- Secondary Outcome Measures
Name Time Method 1. Other PK parameters of a free form and a metabolite of atorvastatin<br>2. The PK parameters of a free form and metabolites of DS-8500a<br>3. Safety