Current Therapeutic Research - Clinical and Experimental · Published 2025-01-01 · DOI 10.1016/j.curtheres.2025.100779
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 dose of test or reference product, separated by a 7-days washout period. Primary endpoints included PK parameters (Cmax, AUC0-t, AUC0-inf) for ibuprofen and diphenhydramine. Secondary endpoints were tmax, t1/2, Cl/F, Vz/F, and λZ. Safety assessments covered adverse events, lab results, and physical exams. Results: Forty-four subjects were randomized, 42 completed both treatment periods for ibuprofen and 41 for diphenhydramine. The population was balanced in age, BMI, and gender, predominantly Hispanic/Latino. Mean Cmax values for test and reference products were comparable, with a median tmax of 3 hours for diphenhydramine (both test and reference) and 1 hour (test) and 0.875 hour (reference) for ibuprofen. The geometric mean ratios (90% CI) for all pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, and Cmax) were 99.15% (96.76–101.61), 99.20% (96.82–101.63) and 95.13% (88.31–102.47), respectively, for ibuprofen, and 102.62% (98.15–107.30), 102.73% (98.31–107.34), and 102.51% (93.54–112.35), respectively, for diphenhydramine. All values fell within the bioequivalence acceptance criteria of 80%–125%. No serious adverse events were reported, and subjects rated the ease of swallowing positively for both formulations. Conclusion: The new Advil PM Liqui-Gels Minis formulation is bioequivalent to the marketed Advil PM Liqui-Gels. The smaller capsule size may offer a more convenient option for individuals with swallowing difficulties, without compromising the drug's efficacy or safety.
Abstract from DOAJ. Public domain (CC0 1.0).
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