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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

NCT07036861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-06-25

No results posted yet for this study

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

Interventions

DRUG

Ibuprofen 2%

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

DRUG

Ibuprofen 4%

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

DRUG

Ibuprofen 4%

Nurofen dla dzieci Forte pomarańczowy 40 mg/mL, oral suspension (Polish brand name)

Sponsors & Collaborators

  • Berlin-Chemie AG Menarini Group

    lead INDUSTRY

Principal Investigators

  • Greta Burneikaitė, MD, PhD · Vilnius University Hospital Santaros Klinikos

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2024-04-08
Completion
2025-01-31

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07036861 on ClinicalTrials.gov