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To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets

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.
ClinicalTrials.gov Identifier: NCT00913237
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Brief Summary:
To demonstrate the relative bioavailability of Desipramine Hydrochloride 50 mg tablets.

Condition or disease Intervention/treatment Phase
Depression Drug: Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories) Drug: Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, 2-way Crossover Bioavailability Study of Desipramine Hydrochloride 50 mg Tablets
Study Start Date : July 1987
Primary Completion Date : August 1987
Study Completion Date : August 1987

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories)
Drug: Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories)
Active Comparator: 2
Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)
Drug: Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 28 days ]


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Ages Eligible for Study:   19 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.

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): NCT00913237


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Jules Kann, M.D. Biodecision Laboratories

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913237     History of Changes
Other Study ID Numbers: 860520D
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:
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