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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.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Abrika Bupropion 150 mg XL Tablet, single dose Drug: Wellbutrin XL® 150 mg Tablet, single dose Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion XL Tablets Formulation in Fasted, Normal, Healthy Subjects.
Study Start Date : June 2004
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Bupropion




Primary Outcome Measures :
  1. Rate and Extend of Absorption [ Time Frame: 96 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863941


Locations
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United States, Florida
SFBC Ft. Myers, Inc.
Ft. Myers, Florida, United States, 33901
Sponsors and Collaborators
Actavis Inc.
Investigators
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Principal Investigator: Antonio R. Pizarro,, M.D. SFBC Ft. Myers, Inc
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Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00863941    
Other Study ID Numbers: 04-0646-003
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: August 23, 2010
Last Verified: August 2010
Keywords provided by Actavis Inc.:
Bioequivalence
Bupropion
Healthy subjects
Additional relevant MeSH terms:
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Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors