NCT07036861

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Berlin-Chemie AG Menarini Group · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Male and Female Subjects

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-11-06
• Primary completion: 2024-04-08
• Completion: 2025-01-31
• First posted: 2025-06-25
• Last updated: 2025-06-25

Locations

2 sites across 1 country: Lithuania