Healthy VolunteersPhase 1NCT02956512
Phase I Study to Evaluate the Safety of Dexibuprofen 300mg Under Fasting and Fed Conditions
A Phase 1 study testing Dexibuprofen in people with Healthy Volunteers, run by Apsen Farmaceutica S.A. at 1 site in Brazil.
Trial summary
Phase I Study to Evaluate the Safety of Dexibuprofen 300mg (Apsen Pharmaceuticals A / S.) After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dexibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Mar 2019to 6 Sep 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Study, Open-label, Randomized, Parallel to Evaluate the Safety of the 300 mg Dexibuprofen Following Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.
Phase I Study to Evaluate the Safety of Dexibuprofen 300mg (Apsen Pharmaceuticals A / S.) After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.
Read the detailed description
A single oral dose of test medicine will be administered to participants in a practical period with the aid of 200 mL of water at room temperature. During administration, participants should stay in seated position. Participants will be confined at least 12 hours prior to administration and will remain for about 24 hours after the same, totaling about 36 hours of confinement.
After 36 hours of confinement the participantes will proceed to the multi-dose use phase for seven days in fed conditions.
To assess safety, an evaluation of the vital signs, laboratory tests and health status of the participants will be carried out throughout the study.
- Conditions
- Healthy Volunteers
- Being tested
- Dexibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexibuprofenDrug
Dexibuprofen 300mg
| Study group | Role | What they receive |
|---|---|---|
| Dexibuprofen 300mg - Fed | Experimental | Fed condition Receives: Drug: Dexibuprofen |
| Dexibuprofen 300mg - Fasting | Experimental | Fasting condition Receives: Drug: Dexibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of the drug through the incidence and classification of adverse events following single and multiple dose administration.
Adverse events both recorded in the single-dose and multiple-dose
Measured: 40 days
Secondary outcomes (1)
To evaluate the pharmacokinetics of the drug dexibuprofen at 300 mg concentration after
Evaluation of pharmacokinetic parameters: Tmax, Cmax, AUC, DV, Kel, CL and T1/2.
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start18 Mar 2019
- Primary completion12 Jul 2019
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apsen Farmaceutica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dra. Regina Mayumi Doi, MD, Principal investigator, Azidus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956512
- Sponsor's protocol ID
- DEXAPS0716OR-HD
- Status last verified
- Nov 2020
- First submitted
- 1 Nov 2016
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study, Open-label, Randomized, Parallel to Evaluate the Safety of the 300 mg Dexibuprofen Following Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.
- ClinicalTrials.gov ID
- NCT02956512
- Acronym / sponsor ID
- DEXAPS0716OR-HD
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Apsen Farmaceutica S.A.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 7 Nov 2016 (estimated)
- 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.
Phase I Study to Evaluate the Safety of Dexibuprofen 300mg (Apsen Pharmaceuticals A / S.) After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.
Detailed description
A single oral dose of test medicine will be administered to participants in a practical period with the aid of 200 mL of water at room temperature. During administration, participants should stay in seated position. Participants will be confined at least 12 hours prior to administration and will remain for about 24 hours after the same, totaling about 36 hours of confinement.
After 36 hours of confinement the participantes will proceed to the multi-dose use phase for seven days in fed conditions.
To assess safety, an evaluation of the vital signs, laboratory tests and health status of the participants will be carried out throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexibuprofen 300mg - Fed | Experimental | Drug: DexibuprofenFed condition |
| Dexibuprofen 300mg - Fasting | Experimental | Drug: DexibuprofenFasting condition |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| DexibuprofenDexibuprofen 300mg | Drug | Dexibuprofen 300mg - Fasting, Dexibuprofen 300mg - Fed |
Primary outcome
To assess the safety of the drug through the incidence and classification of adverse events following single and multiple dose administration.
Time frame: 40 days
Adverse events both recorded in the single-dose and multiple-dose
1 secondary outcome
To evaluate the pharmacokinetics of the drug dexibuprofen at 300 mg concentration after
Time frame: 36 hours
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 8 Sep 2026.
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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.
Dra. Regina Mayumi Doi, MD principal investigator
Azidus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexibuprofen in people with Healthy Volunteers, run by Apsen Farmaceutica S.A. at 1 site in Brazil.
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 4 inclusion and 9 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 8 Sep 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 Brazil. 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?
To assess the safety of the drug through the incidence and classification of adverse events following single and multiple dose administration. (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.