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:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00946764
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 24, 2009
July 24, 2009
July 2005
September 2005   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 41 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
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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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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.
Both
19 Years to 54 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00946764
AA28312
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
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