Clinical pharmacology study of FYX-051 for subjects with renal insufficiency
Phase 2
- Conditions
- Subjects with renal insufficiency
- Registration Number
- JPRN-jRCT2080221510
- Lead Sponsor
- Fuji Yakuhin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Subjects belonging to the following criteria of inulin clearance (Cin)
Normal group (Cin: 90mL/min/1.73m^2 or more),
Slightly-decreased group (Cin: 60mL/min/1.73m^2 or more, 90mL/min/1.73m^2 under),
Moderately-decreased group (Cin: 30mL/min/1.73m^2 or more, 60mL/min/1.73m^2 under),
Exclusion Criteria
Subject with disease of gut, heart and liver
Subject with surgical history of apparatus digestorius (gut, liver, gallbladder, bile duct, pancreas and so on) and kidney
Subject with AST(GOT) or ALT(GPT) of 100IU/L or more
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method