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To Demonstrate the Relative Bioequivalency of Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914004
First Posted: June 4, 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
  Purpose
To demonstrate the relative bioequivalency of comparing single 100 mg doses Of Cord's 50 mg Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin tablets.

Condition Intervention Phase
Depression Drug: Desipramine HCl 50 mg Tablets Cord Laboratories Drug: Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-Way Crossover Bioequivalency Study Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax

Enrollment: 36
Arms Assigned Interventions
Experimental: 1
Desipramine HCl 50 mg Tablets Cord Laboratories
Drug: Desipramine HCl 50 mg Tablets Cord Laboratories
Active Comparator: 2
Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc
Drug: Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
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.
  Contacts and Locations
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): NCT00914004


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Jules Kann, Ph.D. Biodecision Laboratories
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00914004     History of Changes
Other Study ID Numbers: 8718-D
First Submitted: June 2, 2009
First Posted: June 4, 2009
Last Update Posted: March 28, 2017
Last Verified: June 2009

Keywords provided by Sandoz:
Antidepressant

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