Healthy
Conditions
Keywords
Bioequivalence, Bupropion, Healthy subjects
Brief summary
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.
Detailed description
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
Interventions
A: Experimental Subjects received Abrika formulated products under fed conditions
B: Active comparator Subjects received GlaxoSmithKline formulated products under fed conditions
Sponsors
Actavis Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate and Extend of Absorption | 120 hours |
Countries
United States
Outcome results
None listed