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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

NCT06802185 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-04-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • HALEON

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-04-12
Completion
2025-04-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06802185 on ClinicalTrials.gov