Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations
This study has been completed.
Information provided by:
First received: July 22, 2009
Last updated: April 21, 2010
Last verified: April 2010
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of the 20% and 30% Etoricoxib (MK0663) Formulations|
Further study details as provided by Merck:
Primary Outcome Measures:
- Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib [ Time Frame: Through 120 Hours Postdose ] [ Designated as safety issue: No ]The area under the plasma concentration vs time curve.
- Peak Plasma Concentration (Cmax) for Etoricoxib [ Time Frame: Through 120 Hours Postdose ] [ Designated as safety issue: No ]
|Study Start Date:||November 2002|
|Study Completion Date:||April 2003|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
Active Comparator: A
Etoricoxib, 20% tablet
Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.
Active Comparator: B
Etoricoxib, 30% tablet
Drug: Comparator: etoricoxib
Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.
Contacts and Locations