To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

Sponsor

Sun Pharma Advanced Research Company Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT03567941

Collaborator

(none)

Enrollment

Location

Arms

10.1

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Placebo Drug: Hydrocodon bitartrate-acetaminophen arm 1 Drug: Hydrocodon bitartrate-acetaminophen arm 2 Drug: Reference	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 29, 2017

Actual Primary Completion Date :

Oct 31, 2018

Actual Study Completion Date :

Oct 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Drug Liking [15 weeks]
Visual analog scale on score from 0 to 100

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years.
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.
Difficulty swallowing large number of pills.
Subjects who have had a tattoo or body piercing.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SPARC Site 1	Toronto	Ontario	Canada	M5V 2T3

Sponsors and Collaborators

Sun Pharma Advanced Research Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sun Pharma Advanced Research Company Limited

ClinicalTrials.gov Identifier:

NCT03567941

Other Study ID Numbers:

CLR_16_07

First Posted:

Jun 26, 2018

Last Update Posted:

Apr 29, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acetaminophen

Hydrocodone

Study Results

No Results Posted as of Apr 29, 2019