To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

• Status: Completed
• Trial end date: 2018-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sun Pharma Advanced Research Company Limited
• Treatments: Acetaminophen; Hydrocodone

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.