Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Relative Bioavailability Trial to Investigate the Pharmacokinetics of Two Immediate Release Fixed Dose Combinations of Hydrocodone Bitartrate and Acetaminophen (a New Abuse Deterrent Tablet and a Ma
Brief Summary:
This clinical trial is being conducted to compare concentrations of hydrocodone and acetaminophen in the blood after administration of a new and a marketed tablet formulation under fasted and fed conditions in healthy adults.
This is a randomized, single-site, open-label, 4-treatment, 4-period crossover, single oral dose Phase I trial in 32 healthy male and female subjects.
The trial will consist of an Enrollment Visit, 4 treatment periods (each lasting approximately 60 hours) separated by 3 washout periods (each lasting at least 7 days), and a Final Examination.