NCT07345130

A Bioequivalence Study of Advil Tablet (Mini) (Ibuprofen 200 mg) Versus Advil Tablet (Ibuprofen 200 mg) in Healthy Adult Subjects Under Fasted Conditions and Bioavailability Assessment of Advil Tablet (Mini) Under Fed Conditions

A Randomized, Open-label, Single-Center, Single-Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalence Study of Advil Tablet (Mini) (Ibuprofen 200 mg) to Advil Tablet (Ibuprofen 200 mg) in Healthy Adult Subjects Under Fasted Conditions and Bioavailability Assessment of Advil Tablet (Mini) Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence of Advil Tablet (Mini) (Test Product) to Advil Tablet (Reference Product) under fasted conditions and to characterize the impact of food on the bioavailability of the Test Product under fed conditions.

Detailed description

This will be a randomized, open-label, single-center, single-dose, three-treatment, three-period, six sequence crossover bioequivalence and bioavailability (food effect) study in healthy adult participants with at least a 3-day washout period between treatment administrations. A sufficient number of participants will be screened to randomize approximately 50 participants, to ensure that at least 42 evaluable participants complete the entire study. Participants will be randomly assigned to one of six treatment sequences and will receive a single dose of each (of 3) treatments in each (of 3) periods following a crossover design. Blood will be sampled regularly at scheduled times for 24 hours following treatment in each period to assess the pharmacokinetic parameters.

Conditions

• Bioequivalence
• Bioavailability

Interventions

Type	Name	Description
DRUG	Advil Tablet (Mini) (Test Product)	200 mg Ibuprofen
DRUG	Advil Tablet (Reference Product)	200 mg Ibuprofen

Timeline

• Start date: 2025-12-17
• Primary completion: 2026-02-03
• Completion: 2026-02-03
• First posted: 2026-01-15
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study