Pain, Postoperative Clinical Trial
Official title:
A Relative Bioavailability Trial to Investigate the Pharmacokinetics of Different Amounts of Tablets of Two Immediate Release Fixed Dose Combinations of Hydrocodone Bitartrate 5 mg/Acetaminophen 325 mg (a New Abuse Deterrent Tablet and a Marketed Tablet) Under Fasted Conditions in Healthy Male and Female Adult Subjects
This clinical trial is being conducted to compare concentrations of hydrocodone and
acetaminophen in the blood after administration of different amounts of tablets of a new and
a marketed tablet formulation in healthy adults.
Part 1 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. Part will consist of an Enrollment
Visit, 4 treatment periods (each lasting approximately 90 hours), and a Final Examination.
The treatment periods will be separated by a washout period each lasting at least 7 days.
Part 2 is optional and depending on pharmacokinetic data review after Part 1. It is a
randomized, single-site, open-label, 2-treatment, 2-period crossover, single oral dose part
in healthy male and female subjects. Part 2 will consist of an Enrollment Visit, 2 treatment
periods (each lasting approximately 90 hours) and a Final Examination. The treatment periods
will be separated by a washout period lasting at least 7 days.
Participants must fast for approximately 10 hours prior to administration of Investigational
medicinal product (IMP) and until approximately 4 hours after the administration of the IMP.
n/a
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