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.
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.
