Clinical pharmacology study of Tofogliflozin in patients with hepatic impairment
Phase 1
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-jRCT2080221650
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Patients with hepatic impairment
-Is suspected of having hepatic cirrhosis based on the results of ultrasonography or a CT scan
-Has moderate hepatic impairment (Class B) according to the Child-Pugh Classification
Subjects with normal hepatic function
-Is a healthy subject
Exclusion Criteria
-Has moderate or severe renal impairment
-Has or is suspected of having diabetes
-Has been administered any of the medicines, foods and drinks that can affect the pharmacokinetics of Tofogliflozin within two weeks before administration
Etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics, Safety
- Secondary Outcome Measures
Name Time Method