Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00913237
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
  Purpose
To demonstrate the relative bioavailability of Desipramine Hydrochloride 50 mg tablets.

Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, 2-Way Crossover Bioavailability Study of Desipramine Hydrochloride 50 mg Tablets

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 1987
Study Completion Date: August 1987
Primary Completion Date: August 1987 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913237

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

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

ClinicalTrials.gov processed this record on December 08, 2016