Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01046214

Run by

Teva Pharmaceuticals USA

People needed

8

Starts

2010-01-01

Last updated by the study team

2015-11-20

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• California Clinical Trials — Culver City, California, United States
• California Clinical Trials — Glendale, California, United States

Full record on ClinicalTrials.gov

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