Conditions: Bioequivalence Healthy Subjects
Keywords: bioequivalence etoricoxib healthy subjects pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 28
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: A single oral dose of the test product Exib 120 mg etoricoxib film-coated tablets. arm 2: A single oral dose of the reference product Arcoxia® 120 mg etoricoxib film-coated tablets.

Interventions: intervention 1: Exib 120 mg etoricoxib film-coated tablets intervention 2: Arcoxia® 120 mg etoricoxib film-coated tablets
Intervention descriptions: intervention 1: Oral, COX-2 highly selective, non-steroidal anti-inflammatory generic drug intervention 2: Oral, COX-2 highly selective, non-steroidal anti-inflammatory innovative drug

Protocol document:
Prot_ICF_000.pdf: 









































































































































































































SAP_001.pdf: