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About
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.
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Inclusion and exclusion criteria
Inclusion Criteria:
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:
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:
Females who have discontinued the use of:
Females who started taking:
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.
8 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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