Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

A Multiple-Dose, Double Blind, Double Dummy, Comparative Bioavailability Study of Two Formulations of Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

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.

Study Overview

• Status: Terminated
• Conditions: Depressive Disorder
• Intervention / Treatment: Drug: Bupropion HCl; Drug: Bupropion HCl

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Culver City, California, United States, 90232
      • California Clinical Trials
    • Glendale, California, United States, 91206
      • California Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria

• 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.

• Positive test results for:

  • HIV
  • Hepatitis B surface antigen or Hepatitis C antibody
  • Urine drugs of abuse (i.e. marijuana, amphetamines, barbiturates, cocaine, opiates, methadone, and phencyclidine) Note: any positive test result(s) for benzodiazepine(s) must be assessed by the investigator to determine whether the patient should be excluded from this study.
  • Serum hCG consistent with pregnancy (females only).
• On a special diet within 30 days prior to study admission (e.g. liquid, protein, raw food diet).
• Difficulty fasting or consuming standard meals.
• Participated in another clinical trial or received an investigational product within 45 days prior to Day 1 drug administration.

• Donation or loss of whole blood:

  • Less than or equal to 499 mL within 30 days prior to dosing
  • Greater than or equal to 500 mL within 56 days prior to dosing Note: blood taken for routine medical evaluations totaling less than 50 mL will be permitted.

• Females who have discontinued the use of:

  • implanted, intrauterine, or injected hormonal contraceptives within 6 months prior to Day 1 drug administration, OR
  • oral, intravaginal, or patch hormonal contraceptives within 1 month prior to Day 1 drug administration

• Females who started taking:

  • implanted or intrauterine hormonal contraceptives less than 6 months prior to Day 1 drug administration, OR
  • oral, intravaginal, patch, or injected hormonal contraceptives less than 3 months prior to Day 1 drug administration.
• Females who are pregnant, lactating, or likely to become pregnant during the study.
• Have had a newly applied tattoo or body piercing within 30 days prior to study admission.
• Does not tolerate venipuncture.
• Unable or unwilling to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Budeprion XL™; 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; 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; Other Names: Budeprion XL™; Drug: Bupropion HCl; 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; Other Names: Wellbutrin XL®
ACTIVE_COMPARATOR: Wellbutrin XL®; 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; 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; Other Names: Budeprion XL™; Drug: Bupropion HCl; 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; Other Names: Wellbutrin XL®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparative bioavailability	1 month

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: Lev Gertsik, MD, California Clinical Trials

Study record dates

Study Major Dates

• Study Start: January 1, 2010

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (ESTIMATE): January 11, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: 2008-1668