Clinical trial NCT01046214: Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Depressive Disorder
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2010-01-11
Enrollment: 8
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


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.

Primary outcomes:
measure: Comparative bioavailability
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Culver City
country: United States
facility: California Clinical Trials
state: California
city: Glendale
country: United States
facility: California Clinical Trials
state: California
Study officials:
affiliation: California Clinical Trials
name: Lev Gertsik, MD
role: PRINCIPAL_INVESTIGATOR
References: