HealthyPhase 1NCT07454369

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

A Phase 1 study testing A1: Etoricoxib / Betamethasone in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.), A2: Etoricoxib (Arcoxia®, Laboratorios Schering-Plough, S.A. de C.V.) and A3: Betamethasone (Celestone® Pediatric, Laboratorios Schering-Plough, S.A. de C.V.) in people with Healthy, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: A1: Etoricoxib / Betamethasone in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.), A2: Etoricoxib (Arcoxia®, Laboratorios Schering-Plough, S.A. de C.V.) and A3: Betamethasone (Celestone® Pediatric, Laboratorios Schering-Plough, S.A. de C.V.)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteMexico
Study dates: 24 Oct 2022to 6 Jan 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

- 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.

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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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Department of Pharmacology and Toxicology of the Faculty of Medicine of the Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

Official title: 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

Read the 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
Being tested: A1: Etoricoxib / Betamethasone in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.), A2: Etoricoxib (Arcoxia®, Laboratorios Schering-Plough, S.A. de C.V.), A3: Betamethasone (Celestone® Pediatric, Laboratorios Schering-Plough, S.A. de C.V.)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
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
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.

Study groups in NCT07454369
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: A3: Betamethasone (Celestone® Pediatric, Laboratorios Schering-Plough, S.A. de C.V.)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
The percentage of frequency of appearance of each adverse event was evaluated.
Measured: 1, 15 and 29 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 20226 Jan 2023

First posted6 Mar 2026
Study start24 Oct 2022
Primary completion25 Nov 2022
Study completion6 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07454369
Sponsor's protocol ID: BD EB-Sil No. 122-22
Status last verified: Mar 2026
First submitted: 25 Feb 2026
Last updated: 6 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07454369
Acronym / sponsor ID: BD EB-Sil No. 122-22
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
Study start: 24 Oct 2022 (actual)
Primary completion: 25 Nov 2022 (actual)
Study completion: 6 Jan 2023 (actual)
First posted: 6 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A: Etoricoxib / Betamethasone	Experimental	Drug: A1: Etoricoxib / Betamethasone in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.)Group A: Etoricoxib/ Betamethasone in fixed dose combination. Pharmaceutical form: Tablet. Each tablet contains: * Etoricoxib 90 mg * Betamethasone 0.25 mg Administration way: oral.
Group B: Etoricoxib	Active comparator	Drug: A2: Etoricoxib (Arcoxia®, Laboratorios Schering-Plough, 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.
Group C: Betamethasone	Active comparator	Drug: A3: Betamethasone (Celestone® Pediatric, 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (11 listed)

- 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Group A: Etoricoxib / Betamethasone
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	Group B: Etoricoxib
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.	Drug	Group C: Betamethasone

Primary outcome

Determine the Cmax.
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.
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.
Determine the AUC 0-t
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.
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.
Determine the 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.
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).
Determine the Tmax
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.
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.
Determine the 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.
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).
Determine the T1/2
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.
Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone employing the half time elimination (t1/2) by the quotient of Ln(2) Ke.

1 secondary outcome

Determine the frequency of occurrence of adverse events
Time frame: 1, 15 and 29 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lourdes Garza - Ocañas, Dr. med principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the Cmax. (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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07454369.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.