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Drug-Drug Interaction of Rifampicin and Cyclosporine on Methotrexate Pharmacokinetics in Healthy Subjects

NCT07196449 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-29

No results posted yet for this study

Summary

This study will evaluate how methotrexate is processed in the body when given with low doses of rifampicin or cyclosporine. These drugs may affect how methotrexate is absorbed and cleared, which could change its safety and effectiveness. Healthy volunteers will receive methotrexate with either rifampicin or cyclosporine, and blood samples will be collected to measure drug levels. The findings may help identify possible drug interactions and improve the safe use of methotrexate.

Conditions

  • Drug Drug Interaction (DDI)

Interventions

DRUG

Methotrexate

Methotrexate Tab. 2.5 mg (Korea United Pharm)

DRUG

Rifampicin

Rifampin Cap. 150 mg (Yuhan Corporation)

DRUG

Cyclosporine

Cypol-N Cap. 100 mg (Chong Kun Dang)

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Jae Yong Chung, Professor · Seoul National University Bundang Hospital, Department of Cliniacl Pharmacology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-14
Primary Completion
2025-06-09
Completion
2026-04-14

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07196449 on ClinicalTrials.gov