A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet

March 19, 2013 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Randomized, Open-Label, 2-Period, Crossover Study to Assess the Bioequivalence of Two 30-mg and One 60-mg Hydrocodone Bitartrate Extended-Release Tablet

The primary objective of this study is to assess the bioequivalence of two 30-mg hydrocodone bitartrate extended-release tablets and one 60-mg hydrocodone bitartrate extended-release tablet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States
        • Teva Investigational Site 10471

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent is obtained.
  • The subject can read, speak, and write in English.
  • The subject is a man or woman 18 through 45 years of age, with a body mass index (BMI) of 20.0 to 30.0 kg/m2, inclusive.
  • The subject is in good health as determined by medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, urinalysis, and serology.
  • Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, be using an acceptable method of contraception, and agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug. Acceptable methods of contraception include abstinence or an intrauterine device (known to have a failure rate of less than 1% per year).
  • The subject has a negative alcohol test and urine drug screen (UDS).
  • The subject must be willing and able to comply with study restrictions and to remain at the study center for the required duration of each study drug period during the study.

Exclusion Criteria:

  • The subject has any clinically significant uncontrolled medical conditions (treated or untreated).
  • The subject has a clinically significant deviation from normal in ECG or physical examination findings, as determined by the investigator or the medical monitor.
  • The subject has habitually consumed, within the past 2 years, more than 21 units of alcohol per week, or has a history of alcohol, narcotic, or any other substance abuse as defined by the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision (DSM-IV-TR, American Psychiatric Association 2000). NOTE: A unit of alcohol is equal to 1 ounce of hard liquor, 5 ounces of wine, or 8 ounces of beer.
  • The subject is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
  • The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal (GI) surgery; a history of appendectomy is allowed).
  • The subject has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the 1st dose of study drug, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the 1st dose of study drug.
  • The subject has a known sensitivity or idiosyncratic reaction to hydrocodone or hydromorphone, their related compounds, or to any metabolites, or naltrexone, or any compound listed as being present in a study formulation.
  • Other exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group AB

Subjects in this group will receive study drug in the following sequence:

  • Treatment A: two 30-mg hydrocodone bitartrate extended-release tablets (reference)
  • Treatment B: one 60-mg hydrocodone bitartrate extended-release tablet (test).
Drug: a 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-mg tablet (Treatment B).
Each subject will receive 1 treatment during each administration period. Subjects will receive each of the 2 treatments once. There will be a minimum 14-day washout period between the 2 administrations of study drug. Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period.
Experimental: Treatment Group BA

Subjects in this group will receive study drug in the following sequence:

  • Treatment B: one 60-mg hydrocodone bitartrate extended-release tablet (test).
  • Treatment A: two 30-mg hydrocodone bitartrate extended-release tablets (reference).
Drug: a 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-mg tablet (Treatment B).
Each subject will receive 1 treatment during each administration period. Subjects will receive each of the 2 treatments once. There will be a minimum 14-day washout period between the 2 administrations of study drug. Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observed plasma drug concentration (Cmax)
Time Frame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
To assess the bioequivalence between 30-mg tablets and one 60-mg tablet of the hydrocodone bitartrate extended-release tablet.
Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
Area under the plasma drug concentration by time curve AUC 0-∞
Time Frame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
To assess bioequivalence between two 30-mg tablets and one 60-mg tablet of the hydrocodone bitartrate extended-release tablet.
Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to maximum observed plasma drug concentration (tmax)
Time Frame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
AUC from time 0 to 72 hours after study drug administration (AUC0-72)
Time Frame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
AUC from time 0 to the time of the last measurable drug concentration (AUC0-t)
Time Frame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
Percentage extrapolation, 100x(AUC0-∞-AUC0-t)/AUC0-∞)
Time Frame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
Apparent plasma terminal elimination rate constant (λz) and associated elimination half life (t½)
Time Frame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
Recording of Adverse Events
Time Frame: From ICF signing to 48-72 hours after discharge from the study center following the last administration of the hydrocodone bitartrate extended-release tablet.
To characterize the safety of the hydrocodone bitartrate extended-release tablet in healthy naltrexone-blocked subjects.
From ICF signing to 48-72 hours after discharge from the study center following the last administration of the hydrocodone bitartrate extended-release tablet.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

December 27, 2012

First Submitted That Met QC Criteria

December 27, 2012

First Posted (Estimate)

January 1, 2013

Study Record Updates

Last Update Posted (Estimate)

March 20, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C33237/1106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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