Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

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.