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

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ClinicalTrials.gov Identifier: NCT02259179
Recruitment Status : Completed
First Posted : October 8, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc

Brief 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. The pharmacokinetics of the two drug products will be evaluated separately in the fed and fasted state.

Condition or disease Intervention/treatment Phase
Healthy 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) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Phase 1 Bioequivalence Study of Naltrexone SR/Bupropion SR Combination Trilayer Tablets From Two Manufacturers in Healthy Subjects
Study Start Date : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arm Intervention/treatment
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 Name: 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 Name: Contrave

Drug: Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)



Primary Outcome Measures :
  1. Cmax [ Time Frame: 0-96 hours post-dose ]
    Maximum observed plasma concentration

  2. 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

  3. AUC(0-inf) [ Time Frame: 0-96 hours post-dose ]
    Area under the plasma concentration-time curve from 0 hour extrapolated to infinity



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259179


Locations
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United States, Kansas
Quintiles Phase One Services, LLC
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Investigators
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Study Director: Senior Vice President Head of Global Development Orexigen Therapeutics, Inc
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Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT02259179    
Other Study ID Numbers: NB-240
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014
Keywords provided by Orexigen Therapeutics, Inc:
Obesity
Overweight
Contrave
Antiobesity agents
Antiobesity drugs
Weight loss drug
Bioequivalence
Pharmacokinetic
Additional relevant MeSH terms:
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Naltrexone
Bupropion
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors