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

NCT07454369 | Completed Phase 1

• 1 other identifier: BD EB-Sil No. 122-22
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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).

  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.

  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).

  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.

  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.

Secondary Outcomes (1)

• Determine the frequency of occurrence of adverse events

  1, 15 and 29 days

Study Arms (3)

Group A: Etoricoxib / Betamethasone

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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.)

Interventions

A1: Etoricoxib / Betamethasone in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.) DRUG

Formula: 90 mg/ 0.25 mg. Pharmaceutical Form: Tablet. Dosage: 1 tablet (90 mg/ 0.25 mg) Administration way: oral

Group A: Etoricoxib / Betamethasone

A2: Etoricoxib (Arcoxia®, Laboratorios Schering-Plough, S.A. de C.V.) DRUG

A2: Pharmaceutical Form: Tablet Formula: 90 mg Dosage: 1 tablet of 90 mg Administration way: oral

Group B: Etoricoxib

A3: Betamethasone (Celestone® Pediatric, Laboratorios Schering-Plough, S.A. de C.V.) DRUG

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.

Group C: Betamethasone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subjects must have been accepted by the COFEPRIS research subjects registration database.
• Subjects without a subordinate relationship with the researchers.
• Subjects who have given informed consent in writing.
• Subjects of both genders, aged between 18 and 55 years, Mexicans. - -Subjects with no background of hypersensitivity or allergies to the drug under study or related drugs.
• Body mass index between 18 and 27 kg/m2.
• Healthy subjects, according to the results of the complete clinical history, electrocardiogram and the integration of the results of the clinical analyses, carried out in certified clinical laboratories, without alterations that require a medical intervention as a consequence.
• Subjects with negative results for immunological tests (Anti-HIV, Anti-hepatitis B and C, VDRL).
• Subjects with negative results in drug abuse screening tests: tetrahydrocannabinoids, cocaine and amphetamines.
• Negative (qualitative) pregnancy test for women of childbearing potential without Bilateral tubal obstruction or hysterectomy.
• In the case of women of childbearing age, they must have a birth control method, including barrier methods, non-hormonal intrauterine device, or bilateral tubal obstruction.

You may not qualify if:

• \- Subjects with recent history or physical examination evidence of gastrointestinal, renal, hepatic, endocrine, respiratory, cardiovascular, dermatological, or hematological disease that could affect the pharmacokinetic study of the product in research.
• Subjects who have been exposed to drugs known as liver enzyme inducers or inhibitors or who have taken drugs potentially toxic within 30 days before the start of the study.
• Subjects who have received any medication during the 7 days before the start of the study.
• Subjects who have been hospitalized for any problem during the three months before the start of the study.
• Subjects who have been rejected by the registry database of research subjects of COFEPRIS, for having participated in a clinical study within the three months prior to the start of the study.
• Subjects who have received investigational drugs within the previous 60 days th the start of the study.
• Subjects allergic to the study drug or related drugs.
• Subjects who have ingested alcohol or drinks containing xanthines (coffee, tea, cocoa, chocolate, cola) or who have eaten charcoal-grilled food or grapefruit juice , at least 10 hours before the start of the study or who have smoked tobacco 24 hours before to the start of the internment period.
• Subjects who have donated or lost 450 mL or more of blood within the previous 60 days of the beginning of the study.
• Subjects with a history of drug and/or alcohol abuse according to the DSM-IV-TR Criteria.
• Research subjects who presents alterations in the vital signs recorded during the selection.

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Department of Pharmacology and Toxicology of the Faculty of Medicine of the Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Interventions

Betamethasone; Etoricoxib

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lourdes Garza - Ocañas, Dr. med

  Department of Pharmacology and Toxicology of the Faculty of Medicine of the Universidad Autónoma de Nuevo León.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 6, 2026
• Study Start: October 24, 2022
• Primary Completion: November 25, 2022
• Study Completion: January 6, 2023
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)