Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers

December 10, 2014 updated by: Orexigen Therapeutics, Inc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Quintiles Phase One Services, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female, 18 to 60 years of age, inclusive
  2. Be in good general health, without any clinically significant medical history, physical examination findings, or laboratory results at Screening or Day -1
  3. Body mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening

Exclusion Criteria:

  1. Acute (within 28 days of Day -1) or chronic illness
  2. 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
  3. History of mania or current diagnosis of active psychosis
  4. Acute depressive illness, including new onset of depression or acute exacerbation of symptoms
  5. 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
  6. Use of any over-the-counter medications, including dietary/nutritional and herbal supplements, within 24 hours prior to study drug intake on Day 1
  7. Use of bupropion- or naltrexone-containing products within 28 days prior to Day -1, or history of hypersensitivity or intolerance to naltrexone or bupropion
  8. 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
  9. Hemoglobin concentration <11 g/dL at Screening
  10. Blood pressure >140/90 mm Hg at Screening or Day -1
  11. 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.
  12. Drug or alcohol abuse or dependence within 6 months prior to Screening, or positive urine drug screen at Screening or Day -1
  13. 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
  14. 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)
  15. Inability or unwillingness to consume a standardized high-fat breakfast as provided at the study clinic on Days 1 and 15
  16. 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
  17. Employee or immediate family member of the sponsor (or designee) or study site research staff
  18. Use of any investigational drug, device, or procedure within 30 days prior to Day -1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Fed Group
Reference and test product naltrexone SR/bupropion SR combination trilayer tablets tested in the fed state.
Drug: Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)
Other Names:
  • Contrave
Drug: Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)
Active Comparator: Fasted group
Reference and test product naltrexone SR/bupropion SR combination trilayer tablets tested in the fasted state.
Drug: Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)
Other Names:
  • Contrave
Drug: Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 0-96 hours post-dose
Maximum observed plasma concentration
0-96 hours post-dose
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
0-96 hours post-dose
AUC(0-inf)
Time Frame: 0-96 hours post-dose
Area under the plasma concentration-time curve from 0 hour extrapolated to infinity
0-96 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orexigen Therapeutics, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Senior Vice President Head of Global Development, Orexigen Therapeutics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NB-240

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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