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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

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ClinicalTrials.gov Identifier: NCT00946764
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Brief Summary:
To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.

Condition or disease Intervention/treatment Phase
Depression Drug: Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.) Drug: Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2005
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)
Drug: Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)
Active Comparator: 2
Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)
Drug: Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 41 days ]


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Ages Eligible for Study:   19 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946764


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Gaetano Morelli, M.D. MDS Pharma Services

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946764     History of Changes
Other Study ID Numbers: AA28312
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: July 2009

Keywords provided by Sandoz:
Antidepressant

Additional relevant MeSH terms:
Imipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs