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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863941
Recruitment Status : Completed
First Posted : March 18, 2009
Last Update Posted : August 23, 2010
Sponsor:
Information provided by:
Actavis Inc.

Tracking Information
First Submitted Date  ICMJE March 17, 2009
First Posted Date  ICMJE March 18, 2009
Last Update Posted Date August 23, 2010
Study Start Date  ICMJE June 2004
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
Rate and Extend of Absorption [ Time Frame: 96 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Relative Bioavailability Study of Bupropion XL 150 mg Tablets Under Fasting Conditions
Official Title  ICMJE A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion XL Tablets Formulation in Fasted, Normal, Healthy Subjects.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Abrika Bupropion 150 mg XL Tablet, single dose
    A: Experimental Subjects received Abrika formulated products under fasting conditions
    Other Name: Bupropion
  • Drug: Wellbutrin XL® 150 mg Tablet, single dose
    B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions
    Other Name: Bupropion
Study Arms  ICMJE
  • Experimental: A
    Abrika Bupropion 150 mg XL Tablet, single dose
    Intervention: Drug: Abrika Bupropion 150 mg XL Tablet, single dose
  • Active Comparator: B
    Wellbutrin XL® 150 mg Tablet, single dose
    Intervention: Drug: Wellbutrin XL® 150 mg Tablet, single dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2009)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2004
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00863941
Other Study ID Numbers  ICMJE 04-0646-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meena Venugopal, Director, Clinical R&D, Actavis Inc
Study Sponsor  ICMJE Actavis Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio R. Pizarro,, M.D. SFBC Ft. Myers, Inc
PRS Account Actavis Inc.
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP