To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Hydrocodon bitartrate-acetaminophen arm 1; Drug: Hydrocodon bitartrate-acetaminophen arm 2; Drug: Reference; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03567941

CLR_16_07

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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32 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Single dose

Treatment:

Drug: Reference

Drug: Hydrocodon bitartrate-acetaminophen arm 1

Drug: Hydrocodon bitartrate-acetaminophen arm 2

Drug: Placebo

Hydrocodon bitartrate-acetaminophen arm 1

Experimental group

Description:

Single dose

Treatment:

Drug: Reference

Drug: Hydrocodon bitartrate-acetaminophen arm 1

Drug: Hydrocodon bitartrate-acetaminophen arm 2

Drug: Placebo

Hydrocodon bitartrate-acetaminophen arm 2

Experimental group

Description:

Single dose

Treatment:

Drug: Reference

Drug: Hydrocodon bitartrate-acetaminophen arm 1

Drug: Hydrocodon bitartrate-acetaminophen arm 2

Drug: Placebo

Reference

Active Comparator group

Description:

Single dose

Treatment:

Drug: Reference

Drug: Hydrocodon bitartrate-acetaminophen arm 1

Drug: Hydrocodon bitartrate-acetaminophen arm 2

Drug: Placebo