Can a common Painkiller's cousin pass the safety test?
NCT ID NCT02956512
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
Researchers are running a Phase 1 trial to check how safe a 300 mg dose of dexibuprofen, a pain-relieving drug similar to ibuprofen, is for healthy adults. The study gives the drug once and then repeatedly, both with and without food, to see how the body handles it. Participants are healthy men and women aged 18 to 50. The goal is to record any side effects and measure how the drug moves through the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dexibuprofen 300 mg tablets
- What this could lead to
- If the drug proves safe, it could support its use as a pain reliever and anti-inflammatory, possibly leading to regulatory approval for broader use.
- What could go wrong
- This is an early-phase safety study in healthy volunteers, so it cannot show how well the drug works for any condition. Side effects may still emerge, and results may not apply to people with health issues.
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
-
Mar 2019
- Finished
-
Sep 2019
- 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 Hide 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 30.00 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.
Contacts and locations
Locations
-
Azidus laboratories Ltd.
Valinhos, São Paulo, 03186010, Brazil
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