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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2002-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Etoricoxib, 20% tablet

Group Type ACTIVE_COMPARATOR

etoricoxib

Intervention Type DRUG

Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.

B

Etoricoxib, 30% tablet

Group Type ACTIVE_COMPARATOR

Comparator: etoricoxib

Intervention Type DRUG

Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.

Interventions

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etoricoxib

Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.

Intervention Type DRUG

Comparator: etoricoxib

Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes