Official Title: “A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion Sustained Release Tablets in Fasted, Normal, Healthy Men.”

The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion 150 mg sustained release tablet to that of Wellbutrin SR sustained release tablet after a single, one-tablet dose in fasted subjects.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: April 2006

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion Sustained Release Tablets in Fasted, Normal, Healthy Men.

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Intervention(s) in this Clinical Trial

• Drug: Bupropion 150 mg Extended-Released Tablet, single dose
  • A: Experimental Subjects received Abrika formulated products under fasting conditions
• Drug: Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose
  • B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Bupropion 150 mg Extended-Released Tablet, single dose
• Active Comparator: B
  • Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose

Primary Measures

• Rate and Extend of Absorption
  • Time Frame: 120 hours
    Safety Issue?: No

Inclusion Criteria:

• Is the individual a healthy, normal adult man who volunteers to participate?
• Is he 18-45 years of age, inclusive?
• Is his BMI between 19 and 30, inclusive?
• Is he considered reliable and capable of understanding his responsibility and role in the study?
• Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment

Exclusion Criteria:

• Does the individual have a history of allergy or hypersensitivity to bupropion?
• Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety?
• Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
• Does he have serious psychological illness?
• Does he have significant history (within the past year) or clinical evidence of alcohol or drug abuse?
• Does he have a positive urine drug screen or saliva alcohol screen, or a positive
• HIV-l, or hepatitis B or C screen?
• Has he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation?
• Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period?
• Has he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?
• Is he unable to refrain from the use of all concomitant medications during the study?
• Has he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
• Has he donated plasma during the two week period preceding study initiation?
• Has he received an investigational drug during the 30 day period preceding study initiation?
• Is he a heavy smoker (usually smoking more than 25 cigarettes per day? A yes answer to any of the above questions indicates that the individual is ineligible for enrollment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Actavis Inc.

Overall Clinical Trial Officials and Contacts

Antonio R. Pizarro,, M.D. Principal Investigator SFBC Ft. Myers, Inc  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00865111

Study ID Number: 06-0646-001

ClinicalTrials.gov Identifier: NCT00865111

Health Authority: United States: Institutional Review Board

BUPROPION