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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00864981
First received: March 13, 2009
Last updated: March 18, 2009
Last verified: March 2009

March 13, 2009
March 18, 2009
September 2005
October 2005   (final data collection date for primary outcome measure)
Bioequivalence according to US FDA timelines [ Time Frame: 29 days ] [ Designated as safety issue: No ]
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00864981
B052005
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
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