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Dexibuprofen put to the test: can a common painkiller pass safety checks?

NCT ID NCT02956525

Knowledge-focused Sponsor: Apsen Farmaceutica S.A. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are running a Phase 1 trial to check the safety of 200 mg dexibuprofen, a nonsteroidal anti-inflammatory drug, in healthy adults. The study enrolls 52 men and women aged 18 to 50 with a healthy body weight. Participants receive single and multiple oral doses while fasting or after a meal, and researchers track side effects and how the body processes the drug.

What this could mean

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

Active substance
dexibuprofen, a nonsteroidal anti-inflammatory drug
What this could lead to
If the drug behaves safely and predictably, this could support its use as a pain and inflammation treatment in broader patient groups.
What could go wrong
This is a small, early-stage study in healthy volunteers, so it cannot show whether the drug works for any condition. Side effects such as stomach upset or kidney changes may appear, and results may not apply to people who are sick or taking other medicines.

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

52 people

The number who actually took part.

Started

Apr 2018

Finished

Jul 2018

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 50 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: * Participant able to understand and sign the informed consent of the study; * Healthy research participant, of both sexes, aged between 18 and 50 years, with BMI between 18.50 and 29.99 kg / m2; * Participant considered healthy by evaluating the medical history, vital signs and general clinical examination; * The results of clinical laboratory tests (biochemistry, hematology, serology, urinalysis and ECG certified by cardiologists) within the normal range established by the laboratory or changes that are considered not clinically significant by study physician. Exclusion Criteria: * History of any major surgery in the last three months; * History present or previous history of any cardiac event, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematologic, considered by the investigator as clinically significant and can endanger the participant's health; * History of chronic alcohol abuse, drugs, drugs and / or smoking in the last 6 months; * Known hypersensitivity to dexibuprofen, ibuprofen or its related (other nonsteroidal anti-inflammatory drugs) as well as components present in the formulation; * History of use of drugs that potentially interfere with the kinetics / dynamics dexibuprofen or any other medication considered clinically significant by the investigator with time less than 7 times of drug half-life preceding the period of inclusion; * Regular consumption of grapefruit and / or their derivatives; * Pregnant women and nursing mothers; * Donation or loss of 450 ml or more of blood within 3 months before the study and / or hospitalization for any reason, up to 4 weeks before the beginning of it. * Participation in any clinical trial in the last 12 months preceding the start of the study.

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As listed by the trial registrant

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

Healthy volunteers

Contacts and locations

Locations

  • Azidus laboratories Ltd.

    Valinhos, São Paulo, 13271-130, Brazil

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