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Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers

NCT05014490 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-11-29

Study results available
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Summary

The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" \[Ukraine\]) and a Reference medication (marketed medicinal product Arcoxia® 120 mg etoricoxib film-coated tablets, Marketing Authorisation Holder: UAB "Merck Sharp\&Dohme", Lithuania) in healthy volunteers.

Conditions

  • Bioequivalence
  • Healthy Subjects

Interventions

DRUG

Exib 120 mg etoricoxib film-coated tablets

Oral, COX-2 highly selective, non-steroidal anti-inflammatory generic drug

DRUG

Arcoxia® 120 mg etoricoxib film-coated tablets

Oral, COX-2 highly selective, non-steroidal anti-inflammatory innovative drug

Sponsors & Collaborators

  • Anapharm

    collaborator INDUSTRY

  • Darnitsa Pharmaceutical Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2021-03-24
Completion
2021-03-24

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT05014490 on ClinicalTrials.gov