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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 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

NCT07036861•Berlin-Chemie AG Menarini Group

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. 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.
•2. Healthy male and female subjects aged 18 to 45 years inclusive at the time of ICF signature.
•3. Healthy as determined by an Investigator based on the results of the standard clinical, laboratory and instrumental methods of examination.
•4. Body weight ≥ 50 kg and Body Mass Index (BMI) between ≥ 18.5 and ≤ 30 kg/m2.
•5. Non-smokers (for at least 3 months before screening) verified by a cotinine test at screening.
•6. 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.
•7. 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.

Exclusion Criteria

•1. History or presence of allergies.
•2. Known hypersensitivity or intolerance to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs), fructose and/or any excipient of the IMP.
•3. History of bronchospasm, asthma, rhinitis, angioedema or urticaria associated with the intake of acetylsalicylic acid or other NSAIDs.
•4. 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.
•5. 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.
•6. Cerebrovascular or other active bleeding.
•7. 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.
•8. 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.
•9. History of major abdominal surgery or minor abdominal surgery within 3 months before the first IMP dose.
•10. Clinically significant deviations from the normal parameters (see study protocol Appendix 2 for guidance) in clinical blood count analysis, biochemical blood analysis, urinalysis.
+19 more criteria

Locations (2)

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Key Dates

Start Date

November 6, 2023

Primary Completion Date

April 8, 2024

Completion Date

January 31, 2025

Last Updated

June 25, 2025

Enrollment

ACTUAL participants

Conditions

Healthy Male and Female Subjects

Interventions

Ibuprofen 2%

DRUG

Ibuprofen 4%

DRUG

Ibuprofen 4%

DRUG

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Chinese Healthy Subject

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