Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions
- Registration Number
- NCT01046214
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- 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
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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.
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A history of epilepsy or risk for seizures.
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A previous or current diagnosis of bipolar depression.
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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.
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A previous or current diagnosis of an eating disorder (e.g. bulimia, anorexia nervosa).
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A lifetime history of schizophrenia or schizo-affective disorder.
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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.
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Presence of clinically significant gastrointestinal disease and/or surgery (e.g. gastric bypass surgery) or history of malabsorption within the last year.
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Known history or presence of an allergic sensitivity to bupropion and/or any other drug substances with similar activity.
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Expected changes in use of permitted concomitant medication that will be continued throughout the study.
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Undergoing abrupt discontinuation of sedatives (including benzodiazepines).
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Use of monoamine oxidase inhibitors (MAOI) within 2 weeks prior to study admission.
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Taking medications that interact with CYP2B6 within 30 days prior to Day 1 dosing.
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Taking levodopa, amantadine, drugs that lower seizure threshold (e.g. theophylline, systemic steroids, antipsychotics), and/or on nicotine replacement therapy.
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History of alcohol or drug-dependence by DSM IV criteria within 6 months prior to study admission.
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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).
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On a special diet within 30 days prior to study admission (e.g. liquid, protein, raw food diet).
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Difficulty fasting or consuming standard meals.
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Participated in another clinical trial or received an investigational product within 45 days prior to Day 1 drug administration.
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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.
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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
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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.
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Females who are pregnant, lactating, or likely to become pregnant during the study.
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Have had a newly applied tattoo or body piercing within 30 days prior to study admission.
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Does not tolerate venipuncture.
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Unable or unwilling to provide informed consent.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Budeprion XL™ Bupropion HCl Budeprion XL™ 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the reference-placebo tablet Wellbutrin XL® Bupropion HCl Wellbutrin XL® 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the test-placebo tablet
- Primary Outcome Measures
Name Time Method Comparative bioavailability 1 month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
California Clinical Trials
🇺🇸Glendale, California, United States