A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects

• Status: Completed
• Trial end date: 2022-05-09
• Target enrollment: 0
• Participant gender: Male

Summary

To investigate the effect of rifampicin and febuxostat on pharmacokinetics of methotrexate in healthy volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Febuxostat; Methotrexate; Rifampin

Criteria

Inclusion Criteria:

• Age between 19 to 50, healthy male subjects (at screening)

• 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 has a past or present history of any diseases (eg. liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)

• 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