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A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults

Pain, Postoperative Clinical Trial

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 Marketed Tablet) Administered Under Fasted and Fed Conditions in Healthy Male and Female Adult Subjects

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03137017
Study type Interventional
Source Grünenthal GmbH
Contact
Status Withdrawn
Phase Phase 1
Start date September 2017
Completion date November 2017
View Details
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