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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758978
• Other study ID #: C33237/1106
• Status: Completed
• Phase: Phase 1
• First received: December 27, 2012
• Last updated: March 19, 2013
• Start date: December 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Teva Investigational Site 10471	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma drug concentration (Cmax)	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.	No
Primary	Area under the plasma drug concentration by time curve AUC 0-8	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.	No
Secondary	Time to maximum observed plasma drug concentration (tmax)	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.	No
Secondary	AUC from time 0 to 72 hours after study drug administration (AUC0-72)	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.	No
Secondary	AUC from time 0 to the time of the last measurable drug concentration (AUC0-t)	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.	No
Secondary	Percentage extrapolation, 100x(AUC0-8-AUC0-t)/AUC0-8)	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.	No
Secondary	Apparent plasma terminal elimination rate constant (?z) and associated elimination half life (t½)	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.	No
Secondary	Recording of Adverse Events	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.	Yes