Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-01-31

Brief Summary

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This study aims to determine whether the hydrocodone and acetaminophen exposures following oral dosing of Vycavert are comparable to those following oral dosing of Norco.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A: single dose Vycavert (Test)

Group Type EXPERIMENTAL

Vycavert

Intervention Type DRUG

single dose Vycavert containing 10 mg hydrocodone bitartrate/325 mg acetaminophen

B: single dose Norco (Reference)

Group Type ACTIVE_COMPARATOR

Norco

Intervention Type DRUG

single dose Norco containing 10 mg hydrocodone bitartrate/325 mg acetaminophen

Interventions

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Vycavert

single dose Vycavert containing 10 mg hydrocodone bitartrate/325 mg acetaminophen

Intervention Type DRUG

Norco

single dose Norco containing 10 mg hydrocodone bitartrate/325 mg acetaminophen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria

* Evidence or history of clinically significant disease
* History of obstructive sleep apnea
* Life time history and/or recent evidence of alcohol and/or drug abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes