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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01456520

Run by

Pfizer

People needed

47

Starts

2011-10-01

Expected to finish

2012-01-01

Last updated by the study team

2012-02-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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