At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Exib 120 mg etoricoxib film-coated tablets and Arcoxia® 120 mg etoricoxib film-coated tablets for Bioequivalence and Healthy Subjects. Completed, enrolled 28 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Oral, COX-2 highly selective, non-steroidal anti-inflammatory generic drug
Oral, COX-2 highly selective, non-steroidal anti-inflammatory innovative drug