NCT05014490

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

Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Exib 120 mg Etoricoxib Film-coated Tablets (PrJSC "Pharmaceutical Firm "Darnitsa") and Arcoxia 120 mg Etoricoxib Film-coated Tablets (Merck Sharp&Dohme B.V.) in Healthy, Adult Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Darnitsa Pharmaceutical Company · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-02-24
• Primary completion: 2021-03-24
• Completion: 2021-03-24
• First posted: 2021-08-20
• Last updated: 2024-11-29
• Results posted: 2024-11-29

Locations

1 site across 1 country: Turkey (Türkiye)