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To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00913237
First received: June 2, 2009
Last updated: March 27, 2017
Last verified: June 2009

June 2, 2009
March 27, 2017
July 1987
August 1987   (Final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT00913237 on ClinicalTrials.gov Archive Site
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To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets
Randomized, 2-way Crossover Bioavailability Study of Desipramine Hydrochloride 50 mg Tablets
To demonstrate the relative bioavailability of Desipramine Hydrochloride 50 mg tablets.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
Depression
  • Drug: Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories)
  • Drug: Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)
  • Experimental: 1
    Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories)
    Intervention: Drug: Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories)
  • Active Comparator: 2
    Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)
    Intervention: Drug: Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 1987
August 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.
Sexes Eligible for Study: Male
19 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00913237
860520D
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Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz
Not Provided
Principal Investigator: Jules Kann, M.D. Biodecision Laboratories
Sandoz
June 2009

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