HealthyPhase 1NCT02259179
Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers
A Phase 1 study testing Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets) and Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets) in people with Healthy, run by Orexigen Therapeutics, Inc at 1 site in United States.
Trial summary
This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination trilayer tablets prepared at two different manufacturing sites. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets) and Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2014
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, 18 to 60 years of age, inclusive
- Be in good general health, without any clinically significant medical history, physical examination findings, or laboratory results at Screening or Day -1
- Body mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening
Who cannot join
- Acute (within 28 days of Day -1) or chronic illness
- History (within the last 20 years) of seizures, cranial trauma, bulimia, anorexia nervosa, or other conditions that may predispose the subject to seizures; or previous medical treatment with anticonvulsants of any type
- History of mania or current diagnosis of active psychosis
- Acute depressive illness, including new onset of depression or acute exacerbation of symptoms
- Use of any prescription medication within 14 days prior to Day -1, with the exception of hormonal contraceptive or hormonal replacement therapy (HRT) at a stable dose for at least 28 days prior to Day -1
- Use of any over-the-counter medications, including dietary/nutritional and herbal supplements, within 24 hours prior to study drug intake on Day 1
Show all 18Show fewer
- Use of bupropion- or naltrexone-containing products within 28 days prior to Day -1, or history of hypersensitivity or intolerance to naltrexone or bupropion
- Have donated blood or have had significant blood loss within 90 days prior to Day -1; or have donated plasma within 7 days prior to Day -1
- Hemoglobin concentration <11 g/dL at Screening
- Blood pressure >140/90 mm Hg at Screening or Day -1
- Women who are pregnant or trying to become pregnant, have a positive pregnancy test at Screening or Day -1, are currently breast-feeding, or are of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year prior to Day -1) and are not willing to practice effective birth control. Women who are surgically sterile (including bilateral tubal ligation, tubal occlusion, hysterectomy or oophorectomy) are not considered to be of childbearing potential.
- Drug or alcohol abuse or dependence within 6 months prior to Screening, or positive urine drug screen at Screening or Day -1
- Regular daily use of tobacco products, including inhaled tobacco (e.g., cigarettes, cigars, pipes), chewing tobacco or snuff, or nicotine replacement products (including electronic cigarettes or nicotine vaporizers) within 28 days prior to Day -1
- Unwilling to refrain from consumption of any citrus products (e.g., whole fruit, juice or products containing orange, grapefruit, or pomelo), alcohol or caffeine/xanthine-containing foods or beverages for 48 hours before study drug intake in each treatment period (Days 1 and 15) until 72 hours postdose (Days 4 and 18)
- Inability or unwillingness to consume a standardized high-fat breakfast as provided at the study clinic on Days 1 and 15
- Inability to comply with all required study procedures and schedule, inability to speak and read English, or unwillingness or inability to give written informed consent
- Employee or immediate family member of the sponsor (or designee) or study site research staff
- Use of any investigational drug, device, or procedure within 30 days prior to Day -1
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase One Services, LLC
Overland Park, Kansas, 66211
About this study
Official title: A Phase 1 Bioequivalence Study of Naltrexone SR/Bupropion SR Combination Trilayer Tablets From Two Manufacturers in Healthy Subjects
This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination trilayer tablets prepared at two different manufacturing sites. The pharmacokinetics of the two drug products will be evaluated separately in the fed and fasted state.
- Conditions
- Healthy
- Being tested
- Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets), Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)
- Keywords
- Obesity, Overweight, Contrave, Antiobesity agents, Antiobesity drugs, Weight loss drug, Bioequivalence, Pharmacokinetic
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)Drug
Also called Contrave
Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)Drug
| Study group | Role | What they receive |
|---|---|---|
| Fed Group | Active comparator | Reference and test product naltrexone SR/bupropion SR combination trilayer tablets tested in the fed state. Receives: Drug: Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets); Drug: Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets) |
| Fasted group | Active comparator | Reference and test product naltrexone SR/bupropion SR combination trilayer tablets tested in the fasted state. Receives: Drug: Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets); Drug: Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration
Measured: 0-96 hours post-dose
AUC(0-t)
Area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable concentration
Measured: 0-96 hours post-dose
AUC(0-inf)
Area under the plasma concentration-time curve from 0 hour extrapolated to infinity
Measured: 0-96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orexigen Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Vice President Head of Global Development, Study director, Orexigen Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259179
- Sponsor's protocol ID
- NB-240
- Status last verified
- Dec 2014
- First submitted
- 3 Oct 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Bioequivalence Study of Naltrexone SR/Bupropion SR Combination Trilayer Tablets From Two Manufacturers in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02259179
- Acronym / sponsor ID
- NB-240
- Conditions
- Healthy
- Keywords
- Obesity, Overweight, Contrave, Antiobesity agents, Antiobesity drugs, Weight loss drug, Bioequivalence, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Orexigen Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Oct 2014 (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.
This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination trilayer tablets prepared at two different manufacturing sites. The pharmacokinetics of the two drug products will be evaluated separately in the fed and fasted state.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fed Group | Active comparator | Drug: Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets), Drug: Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)Reference and test product naltrexone SR/bupropion SR combination trilayer tablets tested in the fed state. |
| Fasted group | Active comparator | Drug: Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets), Drug: Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)Reference and test product naltrexone SR/bupropion SR combination trilayer tablets tested in the fasted state. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female, 18 to 60 years of age, inclusive
- Be in good general health, without any clinically significant medical history, physical examination findings, or laboratory results at Screening or Day -1
- Body mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening
Key exclusion criteria (18 listed)
- Acute (within 28 days of Day -1) or chronic illness
- History (within the last 20 years) of seizures, cranial trauma, bulimia, anorexia nervosa, or other conditions that may predispose the subject to seizures; or previous medical treatment with anticonvulsants of any type
- History of mania or current diagnosis of active psychosis
- Acute depressive illness, including new onset of depression or acute exacerbation of symptoms
- Use of any prescription medication within 14 days prior to Day -1, with the exception of hormonal contraceptive or hormonal replacement therapy (HRT) at a stable dose for at least 28 days prior to Day -1
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 |
|---|---|---|
| Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)Also: Contrave | Drug | Fasted group, Fed Group |
| Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets) | Drug | Fasted group, Fed Group |
Primary outcome
Cmax
Time frame: 0-96 hours post-dose
Maximum observed plasma concentration
AUC(0-t)
Time frame: 0-96 hours post-dose
Area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable concentration
AUC(0-inf)
Time frame: 0-96 hours post-dose
Area under the plasma concentration-time curve from 0 hour extrapolated to infinity
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 11 Dec 2014.
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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.
Senior Vice President Head of Global Development study director
Orexigen Therapeutics, Inc
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 Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets) and Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets) in people with Healthy, run by Orexigen Therapeutics, 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 3 inclusion and 18 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 11 Dec 2014. 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?
Cmax (time frame: 0-96 hours post-dose). 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 11 Dec 2014.