A Phase 1 interventional study of A1: Etoricoxib / Betamethasone in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.) and A2: Etoricoxib (Arcoxia®, Laboratorios Schering-Plough, S.A. de C.V.) in Healthy, sponsored by Laboratorios Silanes S.A. de C.V.. Completed at 1 site in Mexico. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Laboratorios Silanes S.A. de C.V. · Phase 1, Interventional, and Treatment
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.
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.
Laboratorios Silanes S.A. de C.V. is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group A: Etoricoxib/ Betamethasone in fixed dose combination. Pharmaceutical form: Tablet. Each tablet contains: * Etoricoxib 90 mg * Betamethasone 0.25 mg Administration way: oral.
Drug: A1: Etoricoxib / Betamethasone in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.)
Group B: Etoricoxib Pharmaceutical form: Tablet. Formula: Each tablet contains 90 mg of Etoricoxib. Dosage: 1 tablet of 90 mg. Administration way: Oral.
Drug: A2: Etoricoxib (Arcoxia®, Laboratorios Schering-Plough, S.A. de C.V.)
Group C: Betamethasone 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.
Drug: A3: Betamethasone (Celestone® Pediatric, Laboratorios Schering-Plough, 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
A2: Pharmaceutical Form: Tablet Formula: 90 mg Dosage: 1 tablet of 90 mg Administration way: oral
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.
Determine the Cmax.
Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone employing the maximum observed concentration following the treatment (Cmax), obtained graphically, from the plasma concentration profile with respect to time.
Time frame: Baseline, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours.
Determine the AUC 0-t
Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone employing the area under the curve from time zero to the last measurable concentration (AUC 0-t) using the linear trapezoidal method.
Time frame: Baseline, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours.
Determine the AUC 0-inf
Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone employing the area under the curve from time zero to infinity calculated (AUC 0-inf).
Time frame: Baseline, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours.
Determine the Tmax
Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone employing the time of the maximum measured concentration (tmax) obtained graphically, from the plasma concentration profile with respect to time.
Time frame: Baseline, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours.
Determine the Ke
Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone employing the elimination rate (Ke), estimated from the terminal linear portion of the plasma concentration profile with respect to time (on a semi-log scale).
Time frame: Baseline, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours.
Determine the T1/2
Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone employing the half time elimination (t1/2) by the quotient of Ln(2) Ke.
Time frame: Baseline, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours.
Determine the frequency of occurrence of adverse events
The percentage of frequency of appearance of each adverse event was evaluated.
Time frame: 1, 15 and 29 days
Plan to share: No
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Laboratorios Silanes S.A. de C.V.