Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)

Organon

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: etoricoxib; Drug: Comparator: etoricoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945035

2009_623

0663-070

MK0663-070

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

A

Active Comparator group

Description:

Etoricoxib, 20% tablet

Treatment:

Drug: etoricoxib

B

Active Comparator group

Description:

Etoricoxib, 30% tablet

Treatment:

Drug: Comparator: etoricoxib