NCT07454369

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

Comparative Bioavailability Study Between Etoricoxib/Betamethasone Tablets 90 mg/0,25 mg From Laboratorios Silanes, SA de CV vs Etoricoxib Tablets 90 mg (Arcoxia®) and Betamethasone Solution 50 mg/100 mL (Celestone® Pediatric) From Laboratorios Schering-Plough SA de CV, Administered Individually or in Combination, in an Open-label, Randomized, Single-dose, 3-period, 6-sequence, 3-treatment Design in Healthy Subjects of Both Genders Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this study is to determine whether there are differences in the magnitude and rate of absorption between the test drug and the reference drugs. The study will be cross-over, randomized, with three periods, three treatments, six sequences, truncated at 72 hours in 42 healthy subjetcs, with a single dose of etoricoxib/betamethasone 90/0.25 mg tablet administered in combination or a tablet of etoricoxib 90 mg, or betamethasone solution 50 mg/100 mL (Celestone® Pediatric) administered individually under fasting conditions, with 250 mL of water and a 14-day washout period between each dose of the test product.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	A1: Etoricoxib / Betamethasone in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.)	Formula: 90 mg/ 0.25 mg. Pharmaceutical Form: Tablet. Dosage: 1 tablet (90 mg/ 0.25 mg) Administration way: oral
DRUG	A2: Etoricoxib (Arcoxia®, Laboratorios Schering-Plough, S.A. de C.V.)	A2: Pharmaceutical Form: Tablet Formula: 90 mg Dosage: 1 tablet of 90 mg Administration way: oral
DRUG	A3: Betamethasone (Celestone® Pediatric, Laboratorios Schering-Plough, S.A. de C.V.)	A3: Pharmaceutical Form: Solution Formula: Each 100 mL of solution contains 50 mg of betamethasone. Dosage: 0.5 mL equivalent to 0.25 mg of betamethasone. Administration way: Oral.

Timeline

• Start date: 2022-10-24
• Primary completion: 2022-11-25
• Completion: 2023-01-06
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: Mexico