Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Vycavert (Drug); Norco (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
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.
Clinical Details
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 NorcoŽ 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 norhydrocodoneCmax 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.
Eligibility
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
Locations and Contacts
Pfizer Investigational Site, New Haven, Connecticut 06511, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2011
Last updated: February 7, 2012
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