A Bioequivalence Study of Advil PM Liqui-Gels Minis (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg) Compared to the Current Marketed Advil PM Liqui-Gels (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg) in Healthy Adult Subjects Under Fasted Conditions

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
This is a single center, single dose, open‐label, randomized, two‐treatment,two‐sequence, two‐period crossover, bioequivalence study in healthy adult participantswith at least a 7‐day washout period. A sufficient number of participants will bescreened to randomize approximately 44 to ensure at least 37 evaluable participantscomplete the entire study. Participants will be randomly assigned to one of 2 treatmentsequences and receive a single dose of one of the treatments in each period following acrossover design.
Epistemonikos ID: 070dab187a20d6631fbda6dca25b1a2569df8c80
First added on: Oct 02, 2023