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

An Open Label, Single Dose, Randomized, Two-Period, Two-Way Crossover Study to Evaluate the Pharmacokinetics and Bioequivalence of Vycavert Tablets Compared to Norco® Tablets in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Vycavert; Drug: Norco

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: single dose Vycavert (Test)	Drug: Vycavert; single dose Vycavert containing 10 mg hydrocodone bitartrate/325 mg acetaminophen
Active Comparator: B: single dose Norco (Reference)	Drug: Norco; single dose Norco containing 10 mg hydrocodone bitartrate/325 mg acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of hydrocodone.	0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of acetaminophen	0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Cmax (maximum plasma concentration) of of hydrocodone	0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Cmax (maximum plasma concentration) of acetaminophen	0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
AUClast of hydromorphone and norhydrocodone	0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Cmax of hydromorphone and norhydrocodone	0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
T1/2 (half life) as data permit of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen	0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Tmax (Time at maximum concentration) of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen	0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Adverse events, vital signs, pulse oximetry and laboratory parameters.	0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 14, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Estimate): February 8, 2012
• Last Update Submitted That Met QC Criteria: February 7, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: pharmacokinetics; acetaminophen; bioequivalence; hydrocodone; moderate to moderately severe pain
• Other Study ID Numbers: B4571001