Comparative Bioavailability Study Between Etoricoxib / Betamethasone Administered Individually or in Combination

Phase 1 Completed 42 enrolled Laboratorios Silanes S.A. de C.V.

RandomizedCrossoverOpen-labelTreatment

Summary

This study seeks to evaluate the comparative bioavailability of etoricoxib/betamethasone tablets 90 mg/0.25 mg test drug, administered in fixed combination vs. etoricoxib tablets 90 mg (Arcoxia®) reference drug, and betamethasone solution 50 mg/100 mL (Celestone® Pediatric) reference drug, administered individually, in a single dose, to 42 healthy mexican research subjects of both genders, under fasting conditions.

Timeline

Start: 2022-10-24
Primary completion: 2022-11-25
Completion: 2023-01-06

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Betamethasone	Other / unclassified	0.25 mg	Oral
Subject	Etoricoxib	Small molecule	90 mg	Oral

Indications

No indication recorded.