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To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets

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ClinicalTrials.gov Identifier: NCT00913809
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Study Description
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Brief Summary:
To demonstrate the relative bioequivalency of Cord's 100 mg Desipramine HCl tablets to Merrell Dow's 100 mg Norpramin tablets.

Condition or disease Intervention/treatment Phase
Depression Drug: Desipramine HCL 100 mg Tablets Cord Laboratories Drug: Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-Way Single Dose Crossover Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets
Study Start Date : December 1987
Actual Primary Completion Date : December 1987
Actual Study Completion Date : December 1987

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Desipramine HCL 100 mg Tablets Cord Laboratories
 Drug: Desipramine HCL 100 mg Tablets Cord Laboratories
Active Comparator: 2
Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc
 Drug: Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc


Outcome Measures
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Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 24 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 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
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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): NCT00913809


Sponsors and Collaborators
Sandoz
Investigators
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Principal Investigator: Jules Kann, Ph.D. Biodecision Laboratories
More Information
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Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913809    
Other Study ID Numbers: 870609-D
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: June 2009
Keywords provided by Sandoz:
Antidepressant
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
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