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Bioequivalence Study of Two Formulations of Etoricoxib Tablets 120 mg in Healthy Volunteers Under Fasting Conditions

NCT04830579 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-04-05

No results posted yet for this study

Summary

This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Arcoxia®, 120 mg film-coated tablets) or the test (Etoricoxib, 120 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

Conditions

  • Bioequivalence

Interventions

DRUG

Etoricoxib film-coated tablet 120 mg

Etoricoxib is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 120 mg of etoricoxib.

DRUG

Arcoxia® film-coated tablet 120 mg

Arcoxia® is manufactured by Frosst Iberica SA, Spain. Each tablet contains 120 mg of etoricoxib.

Sponsors & Collaborators

  • ClinPharmInvest, LLC

    collaborator OTHER

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Alexander Khokhlov · ClinPharmInvest, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-04-10
Primary Completion
2021-04-28
Completion
2021-04-28

Countries

  • Russia

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 NCT04830579 on ClinicalTrials.gov