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

NCT00865111 | Completed Phase 1

• 1 other identifier: 06-0646-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion 150 mg sustained release tablet to that of Wellbutrin SR sustained release tablet after a single, one-tablet dose in fasted subjects.

Conditions

Healthy

Keywords

Bioequivalence; Bupropion; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  120 hours

Study Arms (2)

A

EXPERIMENTAL

Bupropion 150 mg Extended-Released Tablet, single dose

Drug: Bupropion 150 mg Extended-Released Tablet, single dose

B

ACTIVE COMPARATOR

Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose

Drug: Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose

Interventions

Bupropion 150 mg Extended-Released Tablet, single dose DRUG

A: Experimental Subjects received Abrika formulated products under fasting conditions

Also known as: Bupropion

A

Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose DRUG

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

Also known as: Bupropion

B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is the individual a healthy, normal adult man who volunteers to participate?
• Is he 18-45 years of age, inclusive?
• Is his BMI between 19 and 30, inclusive?
• 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

You may not qualify if:

• Does the individual have a history of allergy or hypersensitivity to bupropion?
• 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/her safety?
• Does he have serious psychological illness?
• Does he have significant history (within the past year) 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?
• Has he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation?
• Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period?
• Has he used any prescription drug during the 14-day period prior to study initiation, 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?
• Is he a heavy smoker (usually smoking more than 25 cigarettes per day? A yes answer to any of the above questions indicates that the individual is ineligible for enrollment

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

SFBC Ft. Myers, Inc.

Fort Myers, Florida, 33901, United States

Location

MeSH Terms

Interventions

Bupropion

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Antonio R. Pizarro,, M.D.

  SFBC Ft. Myers, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 19, 2009
• Study Start: March 1, 2006
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

US (1)