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To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

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ClinicalTrials.gov Identifier: NCT03567941
Recruitment Status : Completed
First Posted : June 25, 2018
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

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

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Study Type : Interventional  (Clinical Trial)
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 : December 29, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Drug Liking [ Time Frame: 15 weeks ]
    Visual analog scale on score from 0 to 100



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567941


Locations
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Canada, Ontario
SPARC Site 1
Toronto, Ontario, Canada, M5V 2T3
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited

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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT03567941     History of Changes
Other Study ID Numbers: CLR_16_07
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acetaminophen
Hydrocodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents