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a dose of the hydrocodone bitartrate administered as either two 30-mg or one 60-mg

Phase 1

Pain | Small molecule | Pain |Teva Pharmaceutical Industries Limited|Last Updated: Mar 20, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

a dose of the hydrocodone bitartrate administered as either two 30-mg or one 60-mg · 1 trial · 1 indication

Phase 1 1
NCT01758978A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release TabletPain
COMPLETED54 Analytics
PHASE1COMPLETED
A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
Pain
NCT0175897854
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Study Endpoints

Primary Endpoints

Maximum observed plasma drug concentration (Cmax)
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.

Area under the plasma drug concentration by time curve AUC 0-∞
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.

Secondary Endpoints

Time to maximum observed plasma drug concentration (tmax)
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)
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)
Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Group ABEXPERIMENTALSubjects 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).
Treatment Group BAEXPERIMENTALSubjects 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).

Interventions

NameTypeDescription
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).DRUGEach 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.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ps...

Countries:United States
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