NCT01046214

Brief Summary

The objective of this study is to evaluate the comparative bioavailability between bupropion hydrochloride 300 mg extended release tablets (Teva Pharmaceuticals USA) and Wellbutrin XL® 300 mg extended release tablets (Biovail Pharmaceuticals, Inc.) at steady-state in patients under fasting conditions.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

First QC Date

January 8, 2010

Last Update Submit

November 19, 2015

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Comparative bioavailability

    1 month

Study Arms (2)

Budeprion XL™

EXPERIMENTAL

Budeprion XL™ 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the reference-placebo tablet

Drug: Bupropion HCl

Wellbutrin XL®

ACTIVE COMPARATOR

Wellbutrin XL® 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the test-placebo tablet

Drug: Bupropion HCl

Interventions

Bupropion HClDRUG

Budeprion XL™ 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the reference-placebo tablet

Also known as: Budeprion XL™
Budeprion XL™

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients, 25 years of age or older
  • Diagnosis of any depressive disorder as per DSM IV criteria (except bipolar depression and major depressive disorder with psychotic features). Note: Both patients who are or are not being treated with bupropion or other antidepressants are permitted into the study.
  • Patients must have complained of suffering from adverse events and/or lack of effect when switched from Wellbutrin XL® 300 mg to Budeprion XL™ 300 mg.
  • BMI (kg/m2) Greater than or equal to 19 and less than or equal to 34.
  • No clinically significant abnormal laboratory values
  • No clinically significant findings in a 12-lead electrocardiogram (ECG)
  • No clinically significant findings in vital signs measurements.
  • Be informed of the nature of the study and give written consent prior to receiving any study procedure.

You may not qualify if:

  • Carcinoma within the last 5 years. Note: Patients with basal or squamous cell carcinoma may be permitted into the study on a case by case basis.
  • A history of epilepsy or risk for seizures.
  • A previous or current diagnosis of bipolar depression.
  • A current diagnosis of major depressive episode with psychotic features. Note: Subjects with previous diagnosis of major depressive episode with psychotic features may be included at the investigator's discretion.
  • A previous or current diagnosis of an eating disorder (e.g. bulimia, anorexia nervosa).
  • A lifetime history of schizophrenia or schizo-affective disorder.
  • Significant disease(s) or clinically significant finding(s) in a physical examination determined by an investigator to pose a health concern to the patient while on study.
  • Presence of clinically significant gastrointestinal disease and/or surgery (e.g. gastric bypass surgery) or history of malabsorption within the last year.
  • Known history or presence of an allergic sensitivity to bupropion and/or any other drug substances with similar activity.
  • Expected changes in use of permitted concomitant medication that will be continued throughout the study.
  • Undergoing abrupt discontinuation of sedatives (including benzodiazepines).
  • Use of monoamine oxidase inhibitors (MAOI) within 2 weeks prior to study admission.
  • Taking medications that interact with CYP2B6 within 30 days prior to Day 1 dosing.
  • Taking levodopa, amantadine, drugs that lower seizure threshold (e.g. theophylline, systemic steroids, antipsychotics), and/or on nicotine replacement therapy.
  • History of alcohol or drug-dependence by DSM IV criteria within 6 months prior to study admission.
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

California Clinical Trials

Culver City, California, 90232, United States

Location

California Clinical Trials

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Depressive Disorder

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Lev Gertsik, MD

    California Clinical Trials

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 11, 2010

Study Start

January 1, 2010

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

US(2)