A Relative Bioavailability Study of Bupropion XL 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 XL Tablet to that of Wellbutrin XL® 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 XL 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

• Drug: Abrika Bupropion 150 mg XL Tablet, single dose
  A: Experimental Subjects received Abrika formulated products under fed conditions
  Other Name: Bupropion
• Drug: Wellbutrin XL® 150 mg Tablet, single dose
  B: Active comparator Subjects received GlaxoSmithKline formulated products under fed conditions
  Other Name: Bupropion

• Experimental: A
  Abrika Bupropion 150 mg XL Tablet, single dose
  Intervention: Drug: Abrika Bupropion 150 mg XL Tablet, single dose
• Active Comparator: B
  Wellbutrin XL® 150 mg Tablet, single dose
  Intervention: Drug: Wellbutrin XL® 150 mg Tablet, single dose

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