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NCT03567941 Clinical Trial

To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03567941
Other study ID # CLR_16_07
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 29, 2017
Est. completion date October 31, 2018

Study information
Verified date April 2019
Source Sun Pharma Advanced Research Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Tablet orally administered under fasting
• Hydrocodon bitartrate-acetaminophen arm 1
Tablet orally administered under fasted conditions
• Hydrocodon bitartrate-acetaminophen arm 2
Tablet orally administered under fed conditions
• Reference
Tablet orally administered under fasted conditions

Locations
Country Name City State
Canada SPARC Site 1 Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Sun Pharma Advanced Research Company Limited

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Drug Liking Visual analog scale on score from 0 to 100 15 weeks
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