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The effects of trimethoprim-sulfamethoxazole on the pharmacokinetic parameters of mycophenolate mofetil in healthy volunteers

The effects of trimethoprim-sulfamethoxazole on the pharmacokinetic parameters of mycophenolate mofetil in healthy volunteers

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200518005
Enrollment
30
Registered
2020-05-18
Start date
2020-07-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Healthy volunteers

Interventions

Trimethoprim-sulfamethoxazole is antibiotics commonly used in renal transplant recipients for pneumococcal pneumonia prophylaxis.
Experimental Drug
Trimethoprim-sulfamethoxazole

Sponsors

Faculty of Medicine, Chiang Mai University
Lead Sponsor
Faculty of Medicine&#44
Collaborator
Chiang Mai University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameters 0-48 hours HPLC

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactNut Koonrungsesomboon

Faculty of Medicine, Chiang Mai University

nut.koonrung@cmu.ac.th053935353

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026