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

NCT01456520 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2012-02-08

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Vycavert

single dose Vycavert containing 10 mg hydrocodone bitartrate/325 mg acetaminophen

DRUG

Norco

single dose Norco containing 10 mg hydrocodone bitartrate/325 mg acetaminophen

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456520 on ClinicalTrials.gov