Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Pharmaceuticals USA
• Treatments: Bupropion

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.