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New combo pill for pain and swelling tested in healthy adults

NCT ID NCT07454369

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new tablet that combines two drugs—etoricoxib (for pain and inflammation) and betamethasone (a steroid)—to see how well it is absorbed compared to taking each drug separately. 42 healthy Mexican adults took a single dose of the combination pill or the individual drugs under fasting conditions. The goal was to measure drug levels in the blood and check for any side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Etoricoxib and Betamethasone combination tablet

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

42 people

The number who actually took part.

Started

Oct 2022

Finished

Jan 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * \- 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Monterrey, Nuevo León, 64460, Mexico

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