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

NCT00865462 | Completed Phase 1

• 1 other identifier: 04-0646-004
• Study Type: interventional
• Target: 30
• 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 XL Tablet to that of Wellbutrin XL® 150 mg Tablet after a single, one-tablet dose in subjects fed a standard meal.

Conditions

Healthy

Keywords

Bioequivalence; Bupropion; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  96 hours

Study Arms (2)

A

EXPERIMENTAL

Abrika Bupropion 150 mg XL Tablet, single dose

Drug: Abrika Bupropion 150 mg XL Tablet, single dose

B

ACTIVE COMPARATOR

Wellbutrin XL® 150 mg Tablet, single dose

Drug: Wellbutrin XL® 150 mg Tablet, single dose

Interventions

Abrika Bupropion 150 mg XL Tablet, single dose DRUG

A: Experimental Subjects received Abrika formulated products under fed conditions

Also known as: Bupropion

A

Wellbutrin XL® 150 mg Tablet, single dose DRUG

B: Active comparator Subjects received GlaxoSmithKline formulated products under fed 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 ≤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

You may not qualify if:

• 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

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

SFBC Ft. Myers, Inc.

Fort Myers, Florida, 33901, United States

Location

MeSH Terms

Interventions

Bupropion; Tablets

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

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: July 1, 2004
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

US (1)