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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01456520
Enrollment
47
Registered
2011-10-20
Start date
2011-10-31
Completion date
2012-01-31
Last updated
2012-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

pharmacokinetics, bioequivalence, hydrocodone, acetaminophen, moderate to moderately severe pain

Brief 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.

Interventions

DRUGVycavert

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

DRUGNorco

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

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of hydrocodone.0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of acetaminophen0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Cmax (maximum plasma concentration) of of hydrocodone0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Cmax (maximum plasma concentration) of acetaminophen0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose

Secondary

MeasureTime frame
AUClast of hydromorphone and norhydrocodone0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Adverse events, vital signs, pulse oximetry and laboratory parameters.0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Cmax of hydromorphone and norhydrocodone0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
T1/2 (half life) as data permit of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Tmax (Time at maximum concentration) of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026