Clinical trial NCT00863941: A Relative Bioavailability Study of Bupropion XL 150 mg Tablets Under Fasting Conditions
Official title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion XL Tablets Formulation in Fasted, Normal, Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Bupropion
Healthy subjects
Lead sponsor: Actavis Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.

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 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

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

Primary outcomes:
measure: Rate and Extend of Absorption
timeFrame: 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ft. Myers
country: United States
facility: SFBC Ft. Myers, Inc.
state: Florida
Study officials:
affiliation: SFBC Ft. Myers, Inc
name: Antonio R. Pizarro,, M.D.
role: PRINCIPAL_INVESTIGATOR
References: