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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Abrika Bupropion 150 mg XL Tablet, single dose; Drug: Wellbutrin XL® 150 mg Tablet, single dose

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

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Ft. Myers, Florida, United States, 33901
      • SFBC Ft. Myers, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; Abrika Bupropion 150 mg XL Tablet, single dose	Drug: Abrika Bupropion 150 mg XL Tablet, single dose; A: Experimental Subjects received Abrika formulated products under fasting conditions; Other Names: Bupropion
ACTIVE_COMPARATOR: B; Wellbutrin XL® 150 mg Tablet, single dose	Drug: Wellbutrin XL® 150 mg Tablet, single dose; B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions; Other Names: Bupropion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and Extend of Absorption	96 hours

Collaborators and Investigators

• Sponsor: Actavis Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (ACTUAL): July 1, 2004
• Study Completion (ACTUAL): July 1, 2004

Study Registration Dates

• First Submitted: March 17, 2009
• First Submitted That Met QC Criteria: March 17, 2009
• First Posted (ESTIMATE): March 18, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 23, 2010
• Last Update Submitted That Met QC Criteria: August 19, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy subjects; Bupropion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: 04-0646-003