A Relative Bioavailability Study of Bupropion XL 150 mg Tablets Under Fasting Conditions - Full Text View

Sponsored by:	Actavis Inc.
Information provided by:	Actavis Inc.
ClinicalTrials.gov Identifier:	NCT00863941

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Abrika Bupropion 150 mg XL Tablet, single dose Drug: Wellbutrin XL® 150 mg Tablet, single dose	Phase I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion XL Tablets Formulation in Fasted, Normal, Healthy Subjects.

Resource links provided by NLM:

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by Actavis Inc.:

Primary Outcome Measures:

Rate and Extend of Absorption [ Time Frame: 96 hours ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	June 2004
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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
B: Active Comparator 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

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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863941

Locations

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

Sponsors and Collaborators

Actavis Inc.

Investigators

Principal Investigator:

Antonio R. Pizarro,, M.D.

SFBC Ft. Myers, Inc

More Information

Additional Information:

BUPROPION

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Actavis Inc ( Zaidoon A. Al-Zubaidy, Senior Director, Biopharmaceutics )
Study ID Numbers:	04-0646-003
Study First Received:	March 17, 2009
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00863941 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Actavis Inc.:

Bioequivalence
Bupropion
Healthy subjects

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Dopamine
Bupropion
Psychotropic Drugs

Dopamine Agents
Healthy
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions

Therapeutic Uses
Bupropion
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 11, 2009