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

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

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