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To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00913822
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
History of Changes
  Purpose

To demonstrate the relative bioavailability of Desipramine Hydrochloride tablets.


Condition Intervention Phase
Depression
 Drug: Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)
Drug: Norpramin 100 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: Bioavailability of Desipramine Hydrochloride Tablets

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 22 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 1987
Study Completion Date: December 1987
Primary Completion Date: December 1987 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)
 Drug: Desipramine Hydrochloride 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.)

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913822

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Jules Kann, M.D. University of Pittsburgh
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913822     History of Changes
Other Study ID Numbers: 870609D
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
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Desipramine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidepressive Agents, Tricyclic
 Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013