Trial record 2 of 8 for:    contrave

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Orexigen Therapeutics, Inc
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT02259179
First received: October 3, 2014
Last updated: NA
Last verified: October 2014
History: No changes posted
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase 1 Bioequivalence Study of Naltrexone SR/Bupropion SR Combination Trilayer Tablets From Two Manufacturers in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:
  • Cmax [ Time Frame: 0-96 hours post-dose ] [ Designated as safety issue: No ]
    Maximum observed plasma concentration

  • AUC(0-t) [ Time Frame: 0-96 hours post-dose ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Area under the plasma concentration-time curve from 0 hour extrapolated to infinity


Estimated Enrollment: 80
Study Start Date: September 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02259179

Contacts
Contact: Quintiles Phase One Services, Inc. 913-894-5533

Locations
United States, Kansas
Quintiles Phase One Services, LLC Recruiting
Overland Park, Kansas, United States, 66211
Contact    913-894-5533      
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Investigators
Study Director: Senior Vice President Head of Global Development Orexigen Therapeutics, Inc
  More Information

No publications provided

Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT02259179     History of Changes
Other Study ID Numbers: NB-240
Study First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:
Obesity
Overweight
Contrave
Antiobesity agents
Antiobesity drugs
Weight loss drug
Bioequivalence
Pharmacokinetic

Additional relevant MeSH terms:
Bupropion
Naltrexone
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014