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

NCT00945035 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-02-09

Study results available
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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.

Conditions

Interventions

DRUG

etoricoxib

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

DRUG

Comparator: etoricoxib

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

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2002-12-31
Completion
2002-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00945035 on ClinicalTrials.gov