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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01758978
First received: December 27, 2012
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Pain
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).
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Maximum observed plasma drug concentration (Cmax) [ Time Frame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration. ] [ Designated as safety issue: No ]
    To assess the bioequivalence between 30-mg tablets and one 60-mg tablet of the hydrocodone bitartrate extended-release tablet.

  • 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. ] [ Designated as safety issue: No ]
    To assess bioequivalence between two 30-mg tablets and one 60-mg tablet of the hydrocodone bitartrate extended-release tablet.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.

  • 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. ] [ Designated as safety issue: No ]
    To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.

  • 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. ] [ Designated as safety issue: No ]
    To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.

  • Percentage extrapolation, 100x(AUC0-∞-AUC0-t)/AUC0-∞) [ Time Frame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration. ] [ Designated as safety issue: No ]
    To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.

  • 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. ] [ Designated as safety issue: No ]
    To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.

  • 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. ] [ Designated as safety issue: Yes ]
    To characterize the safety of the hydrocodone bitartrate extended-release tablet in healthy naltrexone-blocked subjects.


Enrollment: 54
Study Start Date: December 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758978

Locations
United States, Texas
Teva Investigational Site 10471
Austin, Texas, United States
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01758978     History of Changes
Other Study ID Numbers: C33237/1106
Study First Received: December 27, 2012
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
bioequivalence, hydrocodone bitartrate extended-release tablets

Additional relevant MeSH terms:
Hydrocodone
Analgesics
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014