DS-8500a midazolam DDI study
Phase 1
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080222622
- 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 45
3) Between the BMI of 18.5 and 25.0
4) HbA1c < 6.5%
5) Between the fasting blood glucose level of 70 mg/dL and 109 mg/d
Exclusion Criteria
1) Presence or history of severe adverse reaction to any drug including midazolam or sensitivity.
2) Presence or history of drug or alcohol abuse. etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The PK parameters of midazolam
- Secondary Outcome Measures
Name Time Method 1) Other PK parameters of free form and metabolites of midazolam<br>2) The PK parameters of DS-8500a<br>3) Safety