Clinical trial NCT01758978: A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: bioequivalence, hydrocodone bitartrate extended-release tablets
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Maximum observed plasma drug concentration (Cmax)
timeFrame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
measure: Area under the plasma drug concentration by time curve AUC 0-∞
timeFrame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
Secondary outcomes:
measure: Time to maximum observed plasma drug concentration (tmax)
timeFrame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
measure: AUC from time 0 to 72 hours after study drug administration (AUC0-72)
timeFrame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
measure: AUC from time 0 to the time of the last measurable drug concentration (AUC0-t)
timeFrame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
measure: Percentage extrapolation, 100x(AUC0-∞-AUC0-t)/AUC0-∞)
timeFrame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
measure: Apparent plasma terminal elimination rate constant (λz) and associated elimination half life (t½)
timeFrame: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
measure: Recording of Adverse Events
timeFrame: From ICF signing to 48-72 hours after discharge from the study center following the last administration of the hydrocodone bitartrate extended-release tablet.
Other outcomes:
Locations:
city: Austin
country: United States
facility: Teva Investigational Site 10471
state: Texas
Study officials:
References: