Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)
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|ClinicalTrials.gov Identifier: NCT00945035|
Recruitment Status : Completed
First Posted : July 23, 2009
Results First Posted : November 17, 2009
Last Update Posted : July 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: etoricoxib Drug: Comparator: etoricoxib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||December 2002|
|Actual Study Completion Date :||December 2002|
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.
- Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib [ Time Frame: Through 120 Hours Postdose ]The area under the plasma concentration vs time curve.
- Peak Plasma Concentration (Cmax) for Etoricoxib [ Time Frame: Through 120 Hours Postdose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945035
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|