bupropion hydrochloride 300 mg extended release tablets under fasting conditions

Conditions: Depressive Disorder

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.


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.