A Relative Bioavailability Study of Bupropion XL 150 mg Tablets Under Fasting Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion XL Tablets Formulation in Fasted, Normal, Healthy Subjects.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Abrika Bupropion 150 mg XL Tablet, single dose
* Drug: Wellbutrin XL® 150 mg Tablet, single dose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Abrika Bupropion 150 mg XL Tablet, single dose | Drug: Abrika Bupropion 150 mg XL Tablet, single dose<br>* A: Experimental Subjects received Abrika formulated products under fasting conditions<br>* Other names: Bupropion;|
| Active Comparator: B<br>Wellbutrin XL® 150 mg Tablet, single dose | Drug: Wellbutrin XL® 150 mg Tablet, single dose<br>* B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions<br>* Other names: Bupropion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and Extend of Absorption |  | 96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Bupropion, Healthy subjects