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Trial record 1 of 1 for:    NCT01456520
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Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco

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ClinicalTrials.gov Identifier: NCT01456520
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : February 8, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 14, 2011
First Posted Date  ICMJE October 20, 2011
Last Update Posted Date February 8, 2012
Study Start Date  ICMJE October 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2011)
  • Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of hydrocodone. [ Time Frame: 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 acetaminophen [ Time Frame: 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 (maximum plasma concentration) of of hydrocodone [ Time Frame: 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 (maximum plasma concentration) of acetaminophen [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2011)
  • Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of hydrocodone. [ Time Frame: 24 hours ]
  • Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of acetaminophen [ Time Frame: 24 hours ]
  • Cmax (maximum plasma concentration) of of hydrocodone [ Time Frame: 24 hours ]
  • Cmax (maximum plasma concentration) of acetaminophen [ Time Frame: 24 hours ]
Change History Complete list of historical versions of study NCT01456520 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2011)
  • AUClast of hydromorphone and norhydrocodone [ Time Frame: 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 norhydrocodone [ Time Frame: 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 ]
  • T1/2 (half life) as data permit of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen [ Time Frame: 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 ]
  • Tmax (Time at maximum concentration) of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen [ Time Frame: 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 ]
  • Adverse events, vital signs, pulse oximetry and laboratory parameters. [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2011)
  • AUClast of hydromorphone and norhydrocodone [ Time Frame: 24 hours ]
  • Cmax of hydromorphone and norhydrocodone [ Time Frame: 24 hours ]
  • T1/2 (half life) as data permit of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen [ Time Frame: 24 hours ]
  • Tmax (Time at maximum concentration) of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen [ Time Frame: 24 hours ]
  • Adverse events, vital signs, pulse oximetry and laboratory parameters. [ Time Frame: 24 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: A: single dose Vycavert (Test)
    Intervention: Drug: Vycavert
  • Active Comparator: B: single dose Norco (Reference)
    Intervention: Drug: Norco
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2012)
47
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2011)
46
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01456520
Other Study ID Numbers  ICMJE B4571001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP