NCT04830579

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

Randomized Crossover Two Period Single Dose Bioequivalence Study of Two Formulations Etoricoxib Tablets 120 mg (Pharmtechnology LLC, Republic of Belarus) and Arcoxia® Tablets 120 mg (Merck Sharp & Dohme B.V., Netherlands) in Healthy Volunteers Under Fasting Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Pharmtechnology LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-04-10
• Primary completion: 2021-04-28
• Completion: 2021-04-28
• First posted: 2021-04-05
• Last updated: 2021-04-05

Locations

1 site across 1 country: Russia