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

NCT07036861 | Completed Phase 1

• 2 other identifiers: BCLT/22/IBU-BE/0012023-503703-28
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Male and Female Subjects

Keywords

Ibuprofen oral suspension; Nurofen oral suspension; Bioequivalence study

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum plasma concentration

  24 hours

• AUC0-t

  Area under the curve

  24 hours

• tmax

  Time to maximum plasma concentration

  24 hours

Secondary Outcomes (4)

• AUC0-inf

  24 hours

• Residual area

  24 hours

• λz

  24 hours

• t1/2

  24 hours

Other Outcomes (5)

• Safety evaluation

  45 days

• Safety evaluation

  45 days

• Safety evaluation

  45 days

Study Arms (3)

Ibuprofen 2% oral suspension (T1), reformulated

EXPERIMENTAL

400 mg to be taken with a graded syringe

Drug: Ibuprofen 2%

Ibuprofen 4% oral suspension (T2), reformulated

EXPERIMENTAL

400 mg to be taken with a graded syringe

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

Drug: Ibuprofen 4%

Interventions

Ibuprofen 2% DRUG

Reformulated Ibuprofen 2% oral suspension (Berlin-Chemie AG)

Ibuprofen 2% oral suspension (T1), reformulated

Ibuprofen 4% DRUG

Reformulated Ibuprofen 4% oral suspension (Berlin-Chemie AG)

Ibuprofen 4% oral suspension (T2), reformulated

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Berlin-Chemie AG Menarini Group: lead

Study Sites (2)

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, LT-08661, Lithuania

Location

Related Links

• Related Info

Study Officials

• Greta Burneikaitė, MD, PhD

  Vilnius University Hospital Santaros Klinikos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, randomized, single-dose, three-period, three treatment, three sequence crossover bioequivalence study

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: November 6, 2023
• Primary Completion: April 8, 2024
• Study Completion: January 31, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

LI (2)