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A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00864981
First Posted: March 19, 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
March 13, 2009
March 19, 2009
March 29, 2017
September 2005
October 2005   (Final data collection date for primary outcome measure)
Bioequivalence according to US FDA timelines [ Time Frame: 29 days ]
Same as current
Complete list of historical versions of study NCT00864981 on ClinicalTrials.gov Archive Site
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A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions
A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions
The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 150 mg SR Tablets under fasting conditions.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Depression
  • Drug: Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.
  • Drug: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline
  • Experimental: 1
    Bupropion HCI ER Tablets, 150 mg
    Intervention: Drug: Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.
  • Active Comparator: 2
    WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg
    Intervention: Drug: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
October 2005
October 2005   (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: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00864981
B052005
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Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz
Not Provided
Principal Investigator: Shirley A Kennedy, M.D. Novum Pharmaceutical Research Services
Sandoz
March 2009

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