A Relative Bioavailability Study of Bupropion XL 150 mg Tablets Under Fasting Conditions
A Relative Bioavailability Study of Bupropion XL 150 mg Tablets Under Fasting Conditions
To compare the rate and extent of absorption of Abrika Bupropion 150 mg XL Tablet to that of
 Wellbutrin XL® 150 mg Tablet after a single, one-tablet dose in fasted subjects.
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 XL Tablets Formulation in Fasted, Normal, Healthy Subjects.

 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