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