Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

Launched by TEVA PHARMACEUTICALS USA · Jan 8, 2010

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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.