Phase 1
Completed N=36
Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)
Source: ClinicalTrials.gov NCT00945035 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcomePrimary: Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib — 32.65; 33.28 µg times hr/mL
Summary
This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib |
32.65; 33.28 | — |
| PRIMARY Peak Plasma Concentration (Cmax) for Etoricoxib |
1964; 2021 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is in good health
- Subject agrees to follow the study guidelines
Exclusion Criteria
- Subject is a smoker
- Subject has a history of adverse reactions caused by NSAIDs or allergies/intolerance to NSAIDs
- Subject is in a situation or has a condition/disease which may interfere with optimal participation in the study
Data sourced from ClinicalTrials.gov (NCT00945035). 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.