A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults

• Status: Withdrawn
• Trial end date: 2018-01-01

Summary

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.

• Phase: Phase 1

Details

• Lead Sponsor: Grünenthal GmbH
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone