A randomized, open-label, 3-way crossover study to assess the pharmacokinetic drug interactions between DS-8500a and a hypoglycemic agent (glimepiride or repaglinide) in Japanese healthy subjects
Phase 1
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080223178
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
1)Japanese
2)Persons who provided written informed consent before the screening examination
3)Persons >= 20 years and =< 45 years of age at the time of informed consent
4)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 at the screening examination
Exclusion Criteria
1)Persons with hypersensitivity or idiosyncratic reactions to a drug, (such as penicillin allergy)
2)Persons with drug or alcohol dependence
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics and safety
- Secondary Outcome Measures
Name Time Method