Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

Official Title: “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.

Intervention(s) in this Clinical Trial

• 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
• 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

Arms, Groups and Cohorts in this Clinical Trial

• 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
• 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

Primary Measures

• Comparative bioavailability
  • Time Frame: 1 month
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Teva Pharmaceuticals USA Industry

Overall Clinical Trial Officials and Contacts

Lev Gertsik, MD Principal Investigator California Clinical Trials  

Overall Contact: Angela Herndon (818) 254-1600 

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01046214

Study ID Number: 2008-1668

ClinicalTrials.gov Identifier: NCT01046214

Health Authority: United States: Institutional Review Board