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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00883155
First Posted: April 17, 2009
Last Update Posted: March 29, 2017
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.
Information provided by:
Sandoz
April 16, 2009
April 17, 2009
March 29, 2017
October 1998
October 1998   (Final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 29 days ]
Same as current
Complete list of historical versions of study NCT00883155 on ClinicalTrials.gov Archive Site
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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: None (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.
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00883155
B-09018
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Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz
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