To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

April 26, 2019 updated by: Sun Pharma Advanced Research Company Limited

A Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 4-Way Crossover Study to Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen 6 × 10/325 mg Tablets Compared to NORCO® 6 × 10/325 mg Tablets and Placebo in Non-Dependent, Recreational Opioid Users When Administered Orally Under Fed and Fasted Conditions

Evaluation of abuse potential in recreational abusers of Hydrocodone Bitartrate and Acetaminophen versus NORCO®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5V 2T3
        • SPARC Site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy male or female subjects 18 to 55 years of age.
  2. Opioid users who have used opioids for recreational purposes and or is an avid opioid user.

Exclusion Criteria:

  1. Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years.
  2. Heavy smoker and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine containing products for at least 6 hours during the in-clinic periods.
  3. Difficulty swallowing large number of pills.
  4. Subjects who have had a tattoo or body piercing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Single dose
Drug: Placebo
Tablet orally administered under fasting
Drug: Hydrocodon bitartrate-acetaminophen arm 1
Tablet orally administered under fasted conditions
Drug: Hydrocodon bitartrate-acetaminophen arm 2
Tablet orally administered under fed conditions
Drug: Reference
Tablet orally administered under fasted conditions
EXPERIMENTAL: Hydrocodon bitartrate-acetaminophen arm 1
Single dose
Drug: Placebo
Tablet orally administered under fasting
Drug: Hydrocodon bitartrate-acetaminophen arm 1
Tablet orally administered under fasted conditions
Drug: Hydrocodon bitartrate-acetaminophen arm 2
Tablet orally administered under fed conditions
Drug: Reference
Tablet orally administered under fasted conditions
EXPERIMENTAL: Hydrocodon bitartrate-acetaminophen arm 2
Single dose
Drug: Placebo
Tablet orally administered under fasting
Drug: Hydrocodon bitartrate-acetaminophen arm 1
Tablet orally administered under fasted conditions
Drug: Hydrocodon bitartrate-acetaminophen arm 2
Tablet orally administered under fed conditions
Drug: Reference
Tablet orally administered under fasted conditions
ACTIVE_COMPARATOR: Reference
Single dose
Drug: Placebo
Tablet orally administered under fasting
Drug: Hydrocodon bitartrate-acetaminophen arm 1
Tablet orally administered under fasted conditions
Drug: Hydrocodon bitartrate-acetaminophen arm 2
Tablet orally administered under fed conditions
Drug: Reference
Tablet orally administered under fasted conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug Liking
Time Frame: 15 weeks
Visual analog scale on score from 0 to 100
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharma Advanced Research Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 29, 2017

Primary Completion (ACTUAL)

October 31, 2018

Study Completion (ACTUAL)

October 31, 2018

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

June 22, 2018

First Posted (ACTUAL)

June 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR_16_07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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