NCT06802185

A Bioequivalence Study of Advil Dual Action Liquid Filled Capsules (125 mg/250 mg) Versus Advil Dual Action Caplets (125 mg/250 mg) and Bioavailability Assessment of Advil Dual Action Liquid Filled Capsules (125 mg/250 mg) and Advil Liqui-Gels (200 mg) in Healthy Adult Subjects

A Randomized, Open Label, Single Oral Dose, Four Treatment, Four Period, Four Sequence, Crossover Bioequivalence Study of Advil Dual Action Liquid Filled Capsules (125 mg/250 mg) vs Advil Dual Action Caplets (125 mg/250 mg) in Healthy Adult Subjects Under Fasted Conditions, and Bioavailability Assessment of Advil Dual Action Liquid Filled Capsules (125 mg/250 mg) Under Fed Conditions and Advil Liqui-Gels (200 mg) Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to demonstrate the bioequivalence of new formulation Advil Dual Action (ADA) liquid filled capsules (Test) compared to the currently marketed ADA Caplet (Reference) under fasted conditions and to assess the relative bioavailability of ADA liquid filled capsules (Test) under fed conditions compared to ADA liquid filled capsules (Reference) under fasted conditions.

Detailed description

This is a single center, single oral dose, open-label, randomized, four-treatment, four period, four sequence, crossover, bioequivalence study of ADA liquid filled capsules (125 milligrams \[mg\] ibuprofen/250 mg acetaminophen) (Treatment A) versus (vs.) ADA Caplets (125 mg ibuprofen/250 mg acetaminophen) (Treatment B) in healthy adult participants under fasted conditions. The study also includes a bioavailability assessment of ADA liquid filled capsules (125 mg ibuprofen/250 mg acetaminophen) under fed conditions (Treatment C) and Advil Liqui-Gels (200 mg ibuprofen) under fasted conditions (Treatment D). A sufficient number of male and female participants will be screened to randomize approximately 54 to ensure at least 48 evaluable participants complete the entire study. Participants will be randomly assigned to 1 of the 4 treatment sequences and receive a single oral dose of the investigational products per the randomization in each period following a crossover design. There will be a wash-out period of 3 days between investigational product administrations. Blood will be sampled regularly at scheduled times for 24 hours following treatment in each period to assess the pharmacokinetic parameters.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	ADA Liquid Filled Capsules (Test Product)	ADA liquid filled capsules containing 125 mg ibuprofen and 250 mg acetaminophen.
DRUG	ADA Caplets (Reference Product)	ADA Caplets containing 125 mg ibuprofen and 250 mg acetaminophen.
DRUG	Advil Liqui-gels (Reference Product)	Advil Liqui-gels containing 200 mg ibuprofen.

Timeline

• Start date: 2025-01-31
• Primary completion: 2025-04-12
• Completion: 2025-04-12
• First posted: 2025-01-31
• Last updated: 2025-04-23

Locations

1 site across 1 country: United States