To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00883155
First received: April 16, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

April 16, 2009
April 16, 2009
October 1998
October 1998   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 29 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions
To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions.

To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets under Fasting Conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Bupropion HCl 100 mg Tablets (Invamed Inc.)
  • Drug: Wellbutrin 100 mg Tablets (Glaxo Wellcome)
  • Experimental: 1
    Bupropion HCl 100 mg Tablets (Invamed Inc.)
    Intervention: Drug: Bupropion HCl 100 mg Tablets (Invamed Inc.)
  • Active Comparator: 2
    Wellbutrin 100 mg Tablets (Glaxo Wellcome)
    Intervention: Drug: Wellbutrin 100 mg Tablets (Glaxo Wellcome)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 1998
October 1998   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00883155
B-09018
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
Not Provided
Principal Investigator: Jameel Razack, M.D. Pharma Medica Research Inc.
Sandoz
April 2009

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