Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

NCT ID: NCT01046214

Last Updated: 2015-11-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31

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.

Conditions

Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Bupropion HCl

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Bupropion HCl

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Budeprion XL™; Wellbutrin XL®

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lev Gertsik, MD

Role: PRINCIPAL_INVESTIGATOR

California Clinical Trials

Locations

California Clinical Trials

Culver City, California, United States

California Clinical Trials

Glendale, California, United States

Countries

United States

Other Identifiers

2008-1668

Identifier Type: -

Identifier Source: org_study_id