To investigate the effect of rifampicin and febuxostat on pharmacokinetics of methotrexate in healthy volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Methotrexate oral administration alone
Co-administration of methotrexate and rifampicin
Co-administration of methotrexate and febuxostat
Seoul National University Bundang Hospital
Seoul, South Korea
Compare Cmax of methotrexate
Compare the maximum concentration (Cmax), area under the plasma concentration-time curve to last measurable time point (AUClast) and area under the plasma concentration-time curve from 0 hours to infinite time (AUCinf) of methotrexate
Time frame: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
Compare AUClast of methotrexate
Compare the area under the plasma concentration-time curve to from 0 to last measurable time point (AUClast) of methotrexate
Time frame: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
Compare AUCinf of methotrexate
Compare area under the plasma concentration-time curve from 0 hours to infinite time (AUCinf) of methotrexate
Time frame: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
Compare Cmax of 7-hydroxy methotrexate
Compare the maximum concentration (Cmax) of 7-hydroxy methotrexate
Time frame: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
Compare AUClast of 7-hydroxy methotrexate
Compare area under the plasma concentration-time curve to last measurable time point (AUClast) of 7-hydroxy methotrexate
Time frame: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
Compare AUCinf of 7-hydroxy methotrexate
Compare area under the plasma concentration-time curve from 0 hours to infinite time (AUCinf) of 7-hydroxy methotrexate
Time frame: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
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