The effects of trimethoprim-sulfamethoxazole on the pharmacokinetic parameters of mycophenolate mofetil in healthy volunteers
Phase 4
Completed
- Conditions
- HealthyHealthy volunteers
- Registration Number
- TCTR20200518005
- Lead Sponsor
- Faculty of Medicine, Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Healthy volunteers aged between 18-40 years with a creatinine clearance of >90 mL/min, ALT of <40 IU/L, AST of <35 IU/L, and serum albumin of >3.5 g/L.
Exclusion Criteria
Known contraindication or hypersensitivity to mycophenolate mofetil, trimethoprim-sulfamethoxazole and other sulfa agents, such as sulfonamide or probenecid; known or suspected pregnancy or breast-feeding; chronic liver disease; hematological disorder; immunocompromised condition; taking antibiotics within 3 months prior to enrollment; regular consumption of alcohol, cigarette smoking, or recreational drugs use/addition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters 0-48 hours HPLC
- Secondary Outcome Measures
Name Time Method Safety parameters Until the end of study Physical examination and laboratory assessments,Genetic variants Day 0 Sequencing,Microbiota Day 0, Day 9, Day 14 Sequencing