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To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00913822
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009

June 2, 2009
June 3, 2009
December 1987
December 1987   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 22 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00913822 on ClinicalTrials.gov Archive Site
Not Provided
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To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets
Bioavailability of Desipramine Hydrochloride Tablets

To demonstrate the relative bioavailability of Desipramine Hydrochloride tablets.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • Drug: Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)
  • Drug: Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)
  • Experimental: 1
    Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)
    Intervention: Drug: Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)
  • Active Comparator: 2
    Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)
    Intervention: Drug: Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 1987
December 1987   (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 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00913822
870609D
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
Not Provided
Principal Investigator: Jules Kann, M.D. University of Pittsburgh
Sandoz
June 2009

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