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

Condition(s) targeted: Healthy

Intervention: Vycavert (Drug); Norco (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of hydrocodone.

Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of acetaminophen

Cmax (maximum plasma concentration) of of hydrocodone

Cmax (maximum plasma concentration) of acetaminophen

Secondary outcome:

AUClast of hydromorphone and norhydrocodone

Cmax of hydromorphone and norhydrocodone

T1/2 (half life) as data permit of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen

Tmax (Time at maximum concentration) of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen

Adverse events, vital signs, pulse oximetry and laboratory parameters.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, New Haven, Connecticut 06511, United States; Recruiting

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

Starting date: October 2011
Last updated: November 22, 2011