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To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00946764
First Posted: July 27, 2009
Last Update Posted: March 28, 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
July 24, 2009
July 27, 2009
March 28, 2017
July 2005
September 2005   (Final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 41 days ]
Same as current
Complete list of historical versions of study NCT00946764 on ClinicalTrials.gov Archive Site
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To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions
To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Depression
  • Drug: Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)
  • Drug: Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)
  • Experimental: 1
    Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)
    Intervention: Drug: Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)
  • Active Comparator: 2
    Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)
    Intervention: Drug: Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 2005
September 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
19 Years to 54 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00946764
AA28312
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Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz
Not Provided
Principal Investigator: Gaetano Morelli, M.D. MDS Pharma Services
Sandoz
July 2009

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