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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Norco
Drug: Vycavert

Study type

Interventional

Funder types

Industry

Identifiers

NCT01456520
B4571001

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

47 participants in 2 patient groups

A: single dose Vycavert (Test)
Experimental group
Treatment:
Drug: Vycavert
B: single dose Norco (Reference)
Active Comparator group
Treatment:
Drug: Norco

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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