Overview

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

Status:
Completed
Trial end date:
2004-07-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Actavis Inc.
Treatments:
Bupropion
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