Seoul National University Bundang Hospital
Seoul, South Korea
NCT Number: NCT05575297
To investigate the effect of rifampicin and febuxostat on pharmacokinetics of methotrexate in healthy volunteers
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Notify Me19 year–45 year
Male
Interventional
Phase 1
Seoul, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Methotrexate oral administration alone
Co-administration of methotrexate and rifampicin
Co-administration of methotrexate and febuxostat
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 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 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 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 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 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 area under the plasma concentration-time curve from 0 hours to infinite time (AUCinf) of 7-hydroxy methotrexate
Seoul National University Hospital
Other
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