Phase 2
Completed N=36
Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration
Source: ClinicalTrials.gov NCT01737944 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX — 118.14; 122.63; 116.71 ng*hr/mL/mg
Summary
Pharmacokinetics (PK) study
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX |
118.14; 122.63; 116.71 | — |
| PRIMARY Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX |
116.60; 121.08; 122.63 | — |
| PRIMARY Bioequivalence Based Upon Dose-Normalized Cmax for MTX |
21.43; 22.38; 23.37 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female >18 years of age with diagnosed Rheumatoid Arthritis(RA).
Exclusion Criteria
- Chronic or acute renal disease
- Any other clinically significant disease or disorder which, in the opinion of the investigator, might put the subject at risk
Data sourced from ClinicalTrials.gov (NCT01737944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.