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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


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Status Withdrawn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

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