A Relative Bioavailability Study of Bupropion Extended-Released 150 mg Tablets Under Fed Conditions
A Relative Bioavailability Study of Bupropion Extended-Released 150 mg Tablets Under Fed Conditions
The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion
 150 mg Extended-Release Tablet to that of Wellbutrin SR® 150 mg Tablet after a single,
 one-tablet dose in subjects fed a standard meal.
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 Extended-Released Tablets Formulation in Normal, Healthy Man Following a
 Standard Meal

 Further study details as provided by Actavis Elizabeth LLC:

 Primary Outcome Measures:

 Rate and Extend of Absorption
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 ≤30?

 -  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, milk
 or eggs?

 -  Does he smoke more than 25 cigarettes/day?

 -  Is he unable to refrain from smoking during the period beginning two hours before and
 ending four hours after study drug administration?

 -  Does he have a history of seizure, cranial trauma, or other predisposition to seizure?

 -  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 safety?

 -  Does he have serious psychological illness?

 -  Does he have significant history (within the past six months) 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?

 -  Is he unable to refrain from the use of alcohol or xanthine-containing foods or
 beverages during periods beginning 24 and 48 hours, respectively, prior to study drug
 administration and ending when the last blood sample has been taken?

 -  Has he used any prescription drug during the 14-day period prior to study initiation
 (except for topical products without systemic absorption), 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? A yes answer to any of the above questions indicates that the individual
 is ineligible for enrollment