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

Last updated on May 9, 2018

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01456520
Pfizer
Completed
Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • 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
  • Experimental: A: single dose Vycavert (Test)
    Intervention: Drug: Vycavert
  • Active Comparator: B: single dose Norco (Reference)
    Intervention: Drug: Norco
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
January 2012
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01456520
B4571001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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