Healthy Male and Female SubjectsPhase 1NCT07036861
A Comparative Bioavailability Study of Reformulated Ibuprofen 2% and 4% Oral Suspensions (Berlin Chemie AG) and Versus Ibuprofen (Nurofen®) 200 mg/5 ml Oral Suspension
A Phase 1 study testing Ibuprofen 2% and Ibuprofen 4% in people with Healthy Male and Female Subjects, run by Berlin-Chemie AG Menarini Group at 2 sites in Lithuania.
Trial summary
Purpose of the study is to compare three different formulations of Ibuprofen oral suspension (liquid taken by mouth) to see if there are any differences in how much of the active substance and how quickly it was taken up by by the body, broken down, and how quickly it was removed from the body. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Male and Female Subjects
- What is being tested?
- Ibuprofen 2% and Ibuprofen 4%
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesLithuania
- Study dates
- 6 Nov 2023to 31 Jan 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of understanding the informed consent form (ICF) and giving signed informed consent which includes compliance with the requirements and restrictions as listed in the ICF and the study protocol.
- Healthy male and female subjects aged 18 to 45 years inclusive at the time of ICF signature.
- Healthy as determined by an Investigator based on the results of the standard clinical, laboratory and instrumental methods of examination.
- Body weight ≥ 50 kg and Body Mass Index (BMI) between ≥ 18.5 and ≤ 30 kg/m2.
- Non-smokers (for at least 3 months before screening) verified by a cotinine test at screening.
- A negative urine pregnancy test (rapid test) within 24 hours before the first IMP dose for female subjects of childbearing potential.
- Postmenopausal (no menses for at least 1 year) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) female subjects are exempted from this requirement.
- Subjects with preserved reproductive potential agree to use, with their partner, adequate contraception throughout the study and for 15 days thereafter (contraceptive methods with reliability greater than 90%: cervical caps with spermicide, diaphragms with spermicide, condoms with intravaginal spermicide, oral, injectable, transdermal or implanted hormonal contraceptives, vaginal contraceptive ring, non-hormonal intrauterine devices), or true sexual abstinence.
Who cannot join
- History or presence of allergies.
- Known hypersensitivity or intolerance to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs), fructose and/or any excipient of the IMP.
- History of bronchospasm, asthma, rhinitis, angioedema or urticaria associated with the intake of acetylsalicylic acid or other NSAIDs.
- History or presence of significant cardiovascular (including congestive heart failure (NYHA IV), arterial hypertension, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, infectious, dermatologic, neurologic, or psychiatric disease.
- History of recurrent peptic ulcer or gastrointestinal bleeding (>2 distinct episodes of proven ulceration or bleeding) or history of gastrointestinal bleeding or perforation related to previous NSAID therapy.
- Cerebrovascular or other active bleeding.
Show all 29Show fewer
- Acute infectious diseases of any organ system (including e.g., influenza, COVID-19, acute respiratory viral infections) less than 4 weeks before the first IMP dose.
- History or presence of any other clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- History of major abdominal surgery or minor abdominal surgery within 3 months before the first IMP dose.
- Clinically significant deviations from the normal parameters (see study protocol Appendix 2 for guidance) in clinical blood count analysis, biochemical blood analysis, urinalysis.
- Systolic blood pressure measured in a supine position < 100 mmHg or > 130 mmHg and/or diastolic blood pressure < 60 mmHg or > 89 mmHg.
- Heart rate < 60 or > 100 beats per minute.
- Female subjects who were attempting to conceive, pregnant or lactating.
- Positive test results for HIV or hepatitis B (HBsAg, anti-HBc) or hepatitis C (anti-HCV) or syphilis at screening.
- Positive screen for drugs of abuse or alcohol at screening.
- Positive test result for cotinine in urine at screening.
- Known or suspected drug or alcohol abuse as judged by the Investigator.
- Alcohol consumption more than 10 units of alcohol a week (1 unit = 200 mL of dry wine or 50 mL of strong alcoholic drinks or 500 mL of beer) within 6 months before the first IMP dose.
- Intake of methylxanthine containing substances (e.g., coffee, tea, chocolate, cocoa, energy drinks, cola) as well as citrus fruits and cranberry (including juices, fruit drinks, etc.) within the last 24 h before the first IMP dose.
- Intake of medications that had a significant effect on circulatory dynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, NSAIDs, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, diuretics, etc.) within the 2 months before the first IMP dose.
- Use of any prescribed or nonprescribed medication, herbal remedies, vitamins and minerals within the 2 weeks before the first IMP dose or longer (at least 5 elimination half-lives) if the medication has a long half-life.
- Mental, physical and other reasons that did not allow the subjects according to Investigator's opinion to assess their behavior adequately, to follow correctly the requirements of the clinical study protocol and to assess the expected risks and possible discomfort.
- Dehydration (e.g. due to diarrhea, vomiting, or other causes) within the last 48 h before the first IMP dose.
- Subjects who had been on a special diet (for whatever reason, e.g., vegetarians or hypocaloric diet [< 1000 kcal/day]) within the 28 days before the first IMP dose.
- Plasma donation within 1 month of screening or blood donation/blood loss >500 mL within the 3 months before screening.
- Unwillingness or inability to follow the procedures and restrictions outlined in the protocol and the ICF.
- Participation in another clinical study within the 3 months before the first IMP dose in this study.
- Female subjects with childbearing potential, having unprotected sexual intercourse with any unsterilized male partner (i.e., a man who is not sterilized by vasectomy for at least 6 months) within the 30 days before the first IMP dose.
- Any reason in the opinion of the Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
2 sites in 1 country.
Lithuania2 sites
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08661
About this study
Official title: A Comparative Bioavailability of Reformulated Ibuprofen 2% and 4% Oral Suspensions (Berlin Chemie AG) and Reference Ibuprofen (Nurofen®) 200 mg/5 ml Oral Suspension in Healthy Male and Female Adult Subjects Under Fasting Conditions: an Open-label, Randomized, Single-dose, Three-period, Three-treatment, Three-sequence Crossover Study
Purpose of the study is to compare three different formulations of Ibuprofen oral suspension (liquid taken by mouth) to see if there are any differences in how much of the active substance and how quickly it was taken up by by the body, broken down, and how quickly it was removed from the body.
Read the detailed description
In this Phase 1 study, two test medications (reformulated Ibuprofen 2% oral suspension and Ibuprofen 4% oral suspension) were compared with the reference medication (Ibuprofen 4% oral suspension marketed under the trade name Nurofen dla dzieci Forte pomarańczowy 40 mg/mL, oral suspension) in terms of bioequovalence of the tested formulations.
- Conditions
- Healthy Male and Female Subjects
- Being tested
- Ibuprofen 2%, Ibuprofen 4%
- Keywords
- Ibuprofen oral suspension, Nurofen oral suspension, Bioequivalence study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 2%Drug
Reformulated Ibuprofen 2% oral suspension (Berlin-Chemie AG)
Ibuprofen 4%Drug
Reformulated Ibuprofen 4% oral suspension (Berlin-Chemie AG)
Ibuprofen 4%Drug
Nurofen dla dzieci Forte pomarańczowy 40 mg/mL, oral suspension (Polish brand name)
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen 2% oral suspension (T1), reformulated | Experimental | 400 mg to be taken with a graded syringe Receives: Drug: Ibuprofen 2% |
| Ibuprofen 4% oral suspension (T2), reformulated | Experimental | 400 mg to be taken with a graded syringe Receives: Drug: Ibuprofen 4% |
| Nurofen dla dzieci Forte pomarańczowy 40 mg/mL, oral suspension, Reckitt-Benckiser (Poland) S.A. | Active comparator | 400 mg to be taken with a graded syringe Receives: Drug: Ibuprofen 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration
Measured: 24 hours
AUC0-t
Area under the curve
Measured: 24 hours
tmax
Time to maximum plasma concentration
Measured: 24 hours
Secondary outcomes (4)
AUC0-inf
Area under the curve to infinity
Measured: 24 hours
Residual area
Measured: 24 hours
λz
elimination constant
Measured: 24 hours
t1/2
Half-life
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start6 Nov 2023
- Primary completion8 Apr 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male and Female SubjectsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open-label, randomized, single-dose, three-period, three treatment, three sequence crossover bioequivalence study
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berlin-Chemie AG Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Greta Burneikaitė, MD, PhD, Principal investigator, Vilnius University Hospital Santaros Klinikos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036861
- Sponsor's protocol ID
- BCLT/22/IBU-BE/001
- Other IDs
- 2023-503703-28, 2023
- Status last verified
- May 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No publication in an ICMJE journal is planned
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Bioavailability of Reformulated Ibuprofen 2% and 4% Oral Suspensions (Berlin Chemie AG) and Reference Ibuprofen (Nurofen®) 200 mg/5 ml Oral Suspension in Healthy Male and Female Adult Subjects Under Fasting Conditions: an Open-label, Randomized, Single-dose, Three-period, Three-treatment, Three-sequence Crossover Study
- ClinicalTrials.gov ID
- NCT07036861
- Acronym / sponsor ID
- BCLT/22/IBU-BE/001
- Conditions
- Healthy Male and Female Subjects
- Keywords
- Ibuprofen oral suspension, Nurofen oral suspension, Bioequivalence study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Berlin-Chemie AG Menarini GroupIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 25 Jun 2025 (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.
Purpose of the study is to compare three different formulations of Ibuprofen oral suspension (liquid taken by mouth) to see if there are any differences in how much of the active substance and how quickly it was taken up by by the body, broken down, and how quickly it was removed from the body.
Detailed description
In this Phase 1 study, two test medications (reformulated Ibuprofen 2% oral suspension and Ibuprofen 4% oral suspension) were compared with the reference medication (Ibuprofen 4% oral suspension marketed under the trade name Nurofen dla dzieci Forte pomarańczowy 40 mg/mL, oral suspension) in terms of bioequovalence of the tested formulations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-label, randomized, single-dose, three-period, three treatment, three sequence crossover bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen 2% oral suspension (T1), reformulated | Experimental | Drug: Ibuprofen 2%400 mg to be taken with a graded syringe |
| Ibuprofen 4% oral suspension (T2), reformulated | Experimental | Drug: Ibuprofen 4%400 mg to be taken with a graded syringe |
| Nurofen dla dzieci Forte pomarańczowy 40 mg/mL, oral suspension, Reckitt-Benckiser (Poland) S.A. | Active comparator | Drug: Ibuprofen 4%400 mg to be taken with a graded syringe |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Capable of understanding the informed consent form (ICF) and giving signed informed consent which includes compliance with the requirements and restrictions as listed in the ICF and the study protocol.
- Healthy male and female subjects aged 18 to 45 years inclusive at the time of ICF signature.
- Healthy as determined by an Investigator based on the results of the standard clinical, laboratory and instrumental methods of examination.
- Body weight ≥ 50 kg and Body Mass Index (BMI) between ≥ 18.5 and ≤ 30 kg/m2.
- Non-smokers (for at least 3 months before screening) verified by a cotinine test at screening.
Key exclusion criteria (29 listed)
- History or presence of allergies.
- Known hypersensitivity or intolerance to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs), fructose and/or any excipient of the IMP.
- History of bronchospasm, asthma, rhinitis, angioedema or urticaria associated with the intake of acetylsalicylic acid or other NSAIDs.
- History or presence of significant cardiovascular (including congestive heart failure (NYHA IV), arterial hypertension, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, infectious, dermatologic, neurologic, or psychiatric disease.
- History of recurrent peptic ulcer or gastrointestinal bleeding (>2 distinct episodes of proven ulceration or bleeding) or history of gastrointestinal bleeding or perforation related to previous NSAID therapy.
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 |
|---|---|---|
| Ibuprofen 2%Reformulated Ibuprofen 2% oral suspension (Berlin-Chemie AG) | Drug | Ibuprofen 2% oral suspension (T1), reformulated |
| Ibuprofen 4%Reformulated Ibuprofen 4% oral suspension (Berlin-Chemie AG) | Drug | Ibuprofen 4% oral suspension (T2), reformulated |
| Ibuprofen 4%Nurofen dla dzieci Forte pomarańczowy 40 mg/mL, oral suspension (Polish brand name) | Drug | Nurofen dla dzieci Forte pomarańczowy 40 mg/mL, oral suspension, Reckitt-Benckiser (Poland) S.A. |
Primary outcome
Cmax
Time frame: 24 hours
Maximum plasma concentration
AUC0-t
Time frame: 24 hours
Area under the curve
tmax
Time frame: 24 hours
Time to maximum plasma concentration
4 secondary outcomes
AUC0-inf
Time frame: 24 hours
Residual area
Time frame: 24 hours
λz
Time frame: 24 hours
t1/2
Time frame: 24 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 25 Jun 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. No publication in an ICMJE journal is planned
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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.
Greta Burneikaitė, MD, PhD principal investigator
Vilnius University Hospital Santaros Klinikos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibuprofen 2% and Ibuprofen 4% in people with Healthy Male and Female Subjects, run by Berlin-Chemie AG Menarini Group at 2 sites in Lithuania.
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 8 inclusion and 29 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 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania. 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?
Cmax (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 25 Jun 2025.