NCT03137030

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid-Related Disorders
• Pain, Acute
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	GRT7014 - Abuse Deterrend Tablet	Single oral dose in one of the four cross-over trial periods and in the standard cross-over trial periods.
DRUG	Norco 5Mg-325Mg Tablet	Single oral dose in one of the four cross-over trial periods and in the standard cross-over trial periods.

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2017-05-02
• Last updated: 2017-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study