NCT03567941

To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sun Pharma Advanced Research Company Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-12-29
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2018-06-26
• Last updated: 2019-04-29

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study