Drug-drug interaction study (2) of Tofogliflozi
Phase 1
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-jRCT2080221710
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 87
Inclusion Criteria
healthy volunteers
-Body mass index (BMI) >=18.5 kg/m2 and <25.0 kg/m2
-eGFR >= 90 mL/min/1.73 m2
-Has not smoked for at least a year before screening and will not smoke during the study period
Etc.
Exclusion Criteria
Has been administered any of the medicines, foods and drinks that can affect the pharmacokinetics of Tofogliflozin or concomitant drugs to be tested for drug-drug interactions within two weeks before administration in Period I
Etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics, Safety<br>Evaluate the pharmacokinetics and safety of Tofogliflozin and concomitant drugs to be tested for drug-drug interactions when administered each other alone or in combination with both.
- Secondary Outcome Measures
Name Time Method