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To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

NCT03567941 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-04-29

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Sun Pharma Advanced Research Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-29
Primary Completion
2018-10-31
Completion
2018-10-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03567941 on ClinicalTrials.gov