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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

NCT03137030 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-07-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2018-01-31
Completion
2018-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03137030 on ClinicalTrials.gov