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To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: June 2, 2009
Last updated: March 27, 2017
Last verified: June 2009
To demonstrate the relative bioavailability of Desipramine Hydrochloride tablets.

Condition Intervention Phase
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
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Bioavailability of Desipramine Hydrochloride Tablets

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 22 days ]

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.)


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00913822

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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. Identifier: NCT00913822     History of Changes
Other Study ID Numbers: 870609D
Study First Received: June 2, 2009
Last Updated: March 27, 2017

Keywords provided by Sandoz:

Additional relevant MeSH terms:
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 processed this record on April 27, 2017