HealthyPhase 1NCT01157169
Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions
A Phase 1 study testing Buprenorphine in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Buprenorphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Sep 2007
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject must be a male or non-pregnant, non-breastfeeding female.
- Subject must be between 18 and 45 years of age (inclusive).
- Subject's Body Mass Index (BMI) must be between 18 and 30 (inclusive), and subject must weigh a minimum of 50 kg (110 lbs).
- Female subjects must agree to utilize one of the following forms of contraception from screening through 4 weeks after completion of the study. Approved forms of contraception are abstinence, double barrier, IUD in place at least 30 days prior to study drug administration, vasectomized partner, surgically sterile for at least 6 months, or at least 2 years postmenopausal.
- Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion of any study-specific procedures.
- Subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for all scheduled outpatient visits.
Who cannot join
- History or presence of any clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
- History or presence of pancreatitis, bowel obstruction, glaucoma, enlargement of the prostate, adrenal disease, hyperthyroidism, or gallbladder disease. Subjects with a history of cholecystectomy for the treatment of gallbladder disease will be excluded.
- Females taking any oral contraceptives including estrogen and progestin combined pills, progestin-only pills, patch, or vaginal ring within 28 days prior to the first dose of study medication; using injectable contraceptives within 6 months of first dose; or who have ever had progestational hormone implants.
- Females taking hormone replacement therapy within 60 days prior to the first dose of study medication.
- Has a clinically significant abnormal finding on the physical exam, medical history, ECG, or clinical laboratory results at screening.
- History or presence of allergic or adverse response to buprenorphine, naltrexone, or any comparable or similar product.
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- Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
- Has donated blood or plasma within 30 days prior to the first dose of study medication.
- Has participated in another clinical trial within 30 days prior to the first dose of study medication.
- Has used any over-the-counter (OTC) medication, including cough and cold preparations, vitamins, and herbal supplements, within 7 days prior to the first dose of study medication.
- Has used any prescription medication within 14 days prior to the first dose of study medication.
- Has consumed beverages or food containing alcohol, caffeine/xanthine, or poppy seeds from 48 hours prior to the first dose of study medication or has consumed beverages or foods containing grapefruit from 14 days prior to the first dose of study medication.
- Has been treated with any known enzyme-altering drugs, such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
- Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
- Has a history of treatment for substance abuse (including alcohol) in the past 5 years.
- Is a female with a positive pregnancy test result.
- Has any piercing of the tongue or has a lip piercing within 30 days prior to the first dose of study medication.
- Has a positive urine screen for drugs of abuse.
- Has a positive urine alcohol test or ethanol breath test.
- Has a positive test for or has been treated for hepatitis B, hepatitis C, or HIV.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions.
The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc. to an equivalent oral dose of the commercially available reference product, Subutex® manufactured by Reckitt Benckiser, following and overnight fast of at least 10 hours.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
- Conditions
- Healthy
- Being tested
- Buprenorphine
- Keywords
- Bioequivalence, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
8 mg Sublingual Tablets
BuprenorphineDrug
Also called Subutex®
8 mg Sublingual Tablets
| Study group | Role | What they receive |
|---|---|---|
| Investigational Test Product | Experimental | Buprenorphine 8 mg Sublingual Tablets Receives: Drug: Buprenorphine |
| Reference Listed Drug | Active comparator | Subutex® 8 mg Sublingual Tablets Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Buprenorphine.
Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma).
Measured: Blood samples collected over a 144 hour period.
AUC0-t for Buprenorphine.
Bioequivalence based on Buprenorphine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Measured: Blood samples collected over a 144 hour period.
AUC0-inf for Buprenorphine.
Bioequivalence based on Buprenorphine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Measured: Blood samples collected over a 144 hour period.
Secondary outcomes (3)
Cmax for Norbuprenorphine.
Informational comparison of Cmax (maximum observed concentration of drug substance in plasma) values for the metabolite Norbuprenorphine.
Measured: Blood samples collected over a 144 hour period.
AUC0-t for Norbuprenorphine.
Informational comparison of AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) values for the metabolite Norbuprenorphine.
Measured: Blood samples collected over a 144 hour period.
AUC0-inf for Norbuprenorphine.
Informational comparison of AUC0-inf (area under the concentration-time curve from time zero to infinity) values for the metabolite Norbuprenorphine.
Measured: Blood samples collected over a 144 hour period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startAug 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frederick A Bieberdorf, M.D., CPI, Principal investigator, CEDRA Clinical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157169
- Sponsor's protocol ID
- 20-A63-AU
- Status last verified
- Jan 2020
- First submitted
- 2 Jul 2010
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01157169
- Acronym / sponsor ID
- 20-A63-AU
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Posted 13 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc. to an equivalent oral dose of the commercially available reference product, Subutex® manufactured by Reckitt Benckiser, following and overnight fast of at least 10 hours.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Test Product | Experimental | Drug: BuprenorphineBuprenorphine 8 mg Sublingual Tablets |
| Reference Listed Drug | Active comparator | Drug: BuprenorphineSubutex® 8 mg Sublingual Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject must be a male or non-pregnant, non-breastfeeding female.
- Subject must be between 18 and 45 years of age (inclusive).
- Subject's Body Mass Index (BMI) must be between 18 and 30 (inclusive), and subject must weigh a minimum of 50 kg (110 lbs).
- Female subjects must agree to utilize one of the following forms of contraception from screening through 4 weeks after completion of the study. Approved forms of contraception are abstinence, double barrier, IUD in place at least 30 days prior to study drug administration, vasectomized partner, surgically sterile for at least 6 months, or at least 2 years postmenopausal.
- Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion of any study-specific procedures.
Key exclusion criteria (20 listed)
- History or presence of any clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
- History or presence of pancreatitis, bowel obstruction, glaucoma, enlargement of the prostate, adrenal disease, hyperthyroidism, or gallbladder disease. Subjects with a history of cholecystectomy for the treatment of gallbladder disease will be excluded.
- Females taking any oral contraceptives including estrogen and progestin combined pills, progestin-only pills, patch, or vaginal ring within 28 days prior to the first dose of study medication; using injectable contraceptives within 6 months of first dose; or who have ever had progestational hormone implants.
- Females taking hormone replacement therapy within 60 days prior to the first dose of study medication.
- Has a clinically significant abnormal finding on the physical exam, medical history, ECG, or clinical laboratory results at screening.
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 |
|---|---|---|
| Buprenorphine8 mg Sublingual Tablets | Drug | Investigational Test Product |
| BuprenorphineAlso: Subutex®8 mg Sublingual Tablets | Drug | Reference Listed Drug |
Primary outcome
Cmax of Buprenorphine.
Time frame: Blood samples collected over a 144 hour period.
Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma).
AUC0-t for Buprenorphine.
Time frame: Blood samples collected over a 144 hour period.
Bioequivalence based on Buprenorphine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
AUC0-inf for Buprenorphine.
Time frame: Blood samples collected over a 144 hour period.
Bioequivalence based on Buprenorphine AUC0-inf (area under the concentration-time curve from time zero to infinity).
3 secondary outcomes
Cmax for Norbuprenorphine.
Time frame: Blood samples collected over a 144 hour period.
AUC0-t for Norbuprenorphine.
Time frame: Blood samples collected over a 144 hour period.
AUC0-inf for Norbuprenorphine.
Time frame: Blood samples collected over a 144 hour period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Frederick A Bieberdorf, M.D., CPI principal investigator
CEDRA Clinical Research, LLC
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 Buprenorphine in people with Healthy, run by Teva Pharmaceuticals USA 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 6 inclusion and 20 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 18 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 13 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax of Buprenorphine. (time frame: Blood samples collected over a 144 hour period.). The study lists 3 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 18 Jan 2020.