PainPhase 1NCT01769677
A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
A Phase 1 study testing 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 people with Pain, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- 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).
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Feb 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, 2-Period, Crossover Study to Assess the Bioequivalence of Two 45-mg and One 90-mg Hydrocodone Bitartrate Extended-Release Tablet
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.
- Conditions
- Pain
- Being tested
- 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).
- Keywords
- Bioequivalence, Hydrocodone bitartrate extended-release tablets
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group AB | Experimental | 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). Receives: 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). |
| Treatment Group BA | Experimental | 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 72 hrs after each dose of study drug
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.
Measured: Up to 72 hrs after each dose of study drug
Secondary outcomes (6)
Time to maximum observed plasma drug concentration (tmax)
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
Measured: Up to 72 hrs after each dose of study drug
AUC from time 0 to 72 hours after study drug administration (AUC0-72)
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
Measured: Up to 72 hrs after each dose of study drug
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.
Measured: Up to 72 hrs after each dose of study drug
Percentage extrapolation, 100x(AUC0-∞-AUC0-t)/AUC0-∞)
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
Measured: Up to 72 hrs after each dose of study drug
Apparent plasma terminal elimination rate constant (λz) and associated elimination half life (t½)
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
Measured: Up to 72 hrs after each dose of study drug
Recording of Adverse Events
To characterize the safety of the hydrocodone bitartrate extended-release tablet in healthy naltrexone-blocked subjects.
Measured: Adverse events will be collected for the duration of the study which is approximately 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769677
- Sponsor's protocol ID
- C33237/1099
- Status last verified
- Mar 2013
- First submitted
- 10 Jan 2013
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, 2-Period, Crossover Study to Assess the Bioequivalence of Two 45-mg and One 90-mg Hydrocodone Bitartrate Extended-Release Tablet
- ClinicalTrials.gov ID
- NCT01769677
- Acronym / sponsor ID
- C33237/1099
- Conditions
- Pain
- Keywords
- Bioequivalence, Hydrocodone bitartrate extended-release tablets
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group AB | Experimental | 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).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). |
| Treatment Group BA | Experimental | 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).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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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).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. | Drug | Treatment Group AB, Treatment Group BA |
Primary outcome
Maximum observed plasma drug concentration (Cmax)
Time frame: Up to 72 hrs after each dose of study drug
To assess the bioequivalence between 45-mg tablets and one 90-mg tablet of the hydrocodone bitartrate extended-release tablet.
Area under the plasma drug concentration by time curve AUC0-∞
Time frame: Up to 72 hrs after each dose of study drug
To assess bioequivalence between two 45-mg tablets and one 90-mg tablet of the hydrocodone bitartrate extended-release tablet.
6 secondary outcomes
Time to maximum observed plasma drug concentration (tmax)
Time frame: Up to 72 hrs after each dose of study drug
AUC from time 0 to 72 hours after study drug administration (AUC0-72)
Time frame: Up to 72 hrs after each dose of study drug
AUC from time 0 to the time of the last measurable drug concentration (AUC0-t)
Time frame: Up to 72 hrs after each dose of study drug
Percentage extrapolation, 100x(AUC0-∞-AUC0-t)/AUC0-∞)
Time frame: Up to 72 hrs after each dose of study drug
Apparent plasma terminal elimination rate constant (λz) and associated elimination half life (t½)
Time frame: Up to 72 hrs after each dose of study drug
Recording of Adverse Events
Time frame: Adverse events will be collected for the duration of the study which is approximately 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 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 people with Pain, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma drug concentration (Cmax) (time frame: Up to 72 hrs after each dose of study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.