Bioequivalence Study of Ibuprofen and Diphenhydramine Hydrochloride mini liquid-filled capsules: A Size Reduction Alternative.

ABSTRACT:

Background

Advil PM Liqui-Gels are widely used to improve the quality of life for individuals experiencing sleep disturbances due to pain. To accommodate those who have difficulty swallowing traditional capsules, Advil PM Liqui-Gels Minis, a smaller capsule variant containing the same composition (ibuprofen/diphenhydramine hydrochloride 200 mg/25 mg) as the original Advil PM Liqui-Gels, was developed as a more manageable alternative.

Objective

Establish the bioequivalence of new size-reduced Advil PM Liqui-Gels Minis (test) compared to the currently marketed Advil PM Liqui-Gels (reference) product under fasting conditions.

Method

This Phase I study was a randomized, open-label, two-treatment, two-sequence, two-period crossover trial. Subjects either received a single

SUBMITTER: Wyatt DJ 

PROVIDER: S-EPMC11930181 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature