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

NCT ID: NCT00863941

Last Updated: 2010-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2004-07-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

A

Abrika Bupropion 150 mg XL Tablet, single dose

Group Type: EXPERIMENTAL

Abrika Bupropion 150 mg XL Tablet, single dose

Intervention Type: DRUG

A: Experimental Subjects received Abrika formulated products under fasting conditions

B

Wellbutrin XL® 150 mg Tablet, single dose

Group Type: ACTIVE_COMPARATOR

Wellbutrin XL® 150 mg Tablet, single dose

Intervention Type: DRUG

B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions

Interventions

Abrika Bupropion 150 mg XL Tablet, single dose

A: Experimental Subjects received Abrika formulated products under fasting conditions

Intervention Type: DRUG

Wellbutrin XL® 150 mg Tablet, single dose

B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions

Intervention Type: DRUG

Other Intervention Names

Bupropion; Bupropion

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Actavis Inc

Principal Investigators

Antonio R. Pizarro,, M.D.

Role: PRINCIPAL_INVESTIGATOR

SFBC Ft. Myers, Inc

Locations

SFBC Ft. Myers, Inc.

Fort Myers, Florida, United States

Countries

United States

Other Identifiers

04-0646-003

Identifier Type: -

Identifier Source: org_study_id