a relative bioavailability study of bupropion xl 150 mg tablets under fed conditions

Conditions: Healthy

Summary: 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

Eligibility criteria:
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

Keywords: bioequivalence bupropion healthy subjects