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:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00914004
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00914004

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

No publications provided

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
Study First Received: June 2, 2009
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Antidepressant

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Desipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014