A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects
NCT ID: NCT05575297
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2021-12-20
2022-05-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Methotrexate
Methotrexate Sodium
Methotrexate oral administration alone
Methotrexate + Rifampicin
Methotrexate + Rifampicin
Methotrexate Sodium
Methotrexate oral administration alone
Rifampicin Sodium
Co-administration of methotrexate and rifampicin
Methotrexate + Febuxostat
Methotrexate + Febuxostat
Methotrexate Sodium
Methotrexate oral administration alone
Febuxostat Tablets
Co-administration of methotrexate and febuxostat
Methotrexate + Rifampicin + Febuxostat
Methotrexate + Rifampicin + Febuxostat
Methotrexate Sodium
Methotrexate oral administration alone
Rifampicin Sodium
Co-administration of methotrexate and rifampicin
Febuxostat Tablets
Co-administration of methotrexate and febuxostat
Interventions
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Methotrexate Sodium
Methotrexate oral administration alone
Rifampicin Sodium
Co-administration of methotrexate and rifampicin
Febuxostat Tablets
Co-administration of methotrexate and febuxostat
Eligibility Criteria
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Inclusion Criteria
* Body weight between 50.0 kg - 90.0 kg, BMI between 18.0 - 30.0 kg/m2
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress
Exclusion Criteria
* Subject who had GI tract disease (Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
* Serum AST(SGOT), ALT(SGPT), total bilirubin \>1.5 times upper limit of normal range, MDRD eGFR \< 60mL/min/1.73m2, WBC count \< 3,500 /uL, SBP \< 90 mmHg or \> 150 mmHg, DBP \< 50 mmHg or \>100 mmHg
* Subject who had galactose intolerance, Lapplactase deficiency or glucose-galactose malabsorption
* Subject who had received drugs inhibiting or inducing metabolic enzymes/transporters such as barbiturates, statins, digoxin in 3 months
* Subject who had taken St.John's wort and food including grapefruit in 2 weeks
* Smoking in 3 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently
19 Years
45 Years
MALE
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jae Yong Chung, MD, PhD
Professor
Locations
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Seoul National University Bundang Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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MRFI
Identifier Type: -
Identifier Source: org_study_id
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