CClinicalTrials.gg
Sign In
CompletedNCT01769677Updated Mar 20, 2013

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

A Phase 1 interventional study of 90 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 45-mg tablets (Treatment A) or one 90-mg tablet (Treatment B). in Pain, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-20.

Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release tablet.

02

Conditions studied

  • Pain

Keywords

  • Bioequivalence
  • Hydrocodone bitartrate extended-release tablets
03

In context

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
  • 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

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 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Treatment Group AB

    Subjects in this group will receive study drug in the following sequence: * Treatment A: two 45-mg hydrocodone bitartrate extended-release tablets (reference). * Treatment B: one 90-mg hydrocodone bitartrate extended-release tablet (test).

    Drug: 90 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 45-mg tablets (Treatment A) or one 90-mg tablet (Treatment B).

  • Experimental
    Treatment Group BA

    Subjects in this group will receive study drug in the following sequence: * Treatment B: one 90-mg hydrocodone bitartrate extended-release tablet (test). * Treatment A: two 45-mg hydrocodone bitartrate extended-release tablets (reference).

    Drug: 90 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 45-mg tablets (Treatment A) or one 90-mg tablet (Treatment B).

Interventions

  • Drug90 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 45-mg tablets (Treatment A) or one 90-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.

06

What researchers measure

Primary outcomes

  1. Maximum observed plasma drug concentration (Cmax)

    To assess the bioequivalence between 45-mg tablets and one 90-mg tablet of the hydrocodone bitartrate extended-release tablet.

    Time frame: Up to 72 hrs after each dose of study drug

  2. Area under the plasma drug concentration by time curve AUC0-∞

    To assess bioequivalence between two 45-mg tablets and one 90-mg tablet of the hydrocodone bitartrate extended-release tablet.

    Time frame: Up to 72 hrs after each dose of study drug

Secondary outcomes

  1. Time to maximum observed plasma drug concentration (tmax)

    To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.

    Time frame: Up to 72 hrs after each dose of study drug

  2. AUC from time 0 to 72 hours after study drug administration (AUC0-72)

    To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.

    Time frame: Up to 72 hrs after each dose of study drug

  3. 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.

    Time frame: Up to 72 hrs after each dose of study drug

  4. Percentage extrapolation, 100x(AUC0-∞-AUC0-t)/AUC0-∞)

    To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.

    Time frame: Up to 72 hrs after each dose of study drug

  5. Apparent plasma terminal elimination rate constant (λz) and associated elimination half life (t½)

    To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.

    Time frame: Up to 72 hrs after each dose of study drug

  6. Recording of Adverse Events

    To characterize the safety of the hydrocodone bitartrate extended-release tablet in healthy naltrexone-blocked subjects.

    Time frame: Adverse events will be collected for the duration of the study which is approximately 7 weeks

07

Study locations

1 site
  • Teva Investigational Site 10470
    Austin, Texas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01769677
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Responsible party
Sponsor
First posted
Jan 17, 2013
Start date
Jan 2013
Primary completion
Jan 2013
Completion
Feb 2013
Last update
Mar 20, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Start the discussion