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Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

Information source: Teva Pharmaceuticals USA
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder

Intervention: Bupropion HCl (Drug); Bupropion HCl (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Lev Gertsik, MD, Principal Investigator, Affiliation: California Clinical Trials

Overall contact:
Angela Herndon, Phone: (818) 254-1600

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.

Clinical Details

Official title: A Multiple-Dose, Double Blind, Double Dummy, Comparative Bioavailability Study of Two Formulations of Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary outcome: Comparative bioavailability

Eligibility

Minimum age: 25 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Angela Herndon, Phone: (818) 254-1600

California Clinical Trials, Culver City, California 90232, United States; Not yet recruiting

California Clinical Trials, Glendale, California 91206, United States; Recruiting

Additional Information

Starting date: January 2010
Last updated: September 20, 2011

Page last updated: December 08, 2011

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