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Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754962
First Posted: September 18, 2008
Last Update Posted: September 18, 2008
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.
Information provided by:
Roxane Laboratories
  Purpose
The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets under fasted conditions

Condition Intervention
Depression Drug: protriptyline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Way Crossover Bioequivalency Study of Protriptyline Tablets 10 mg Under Fasted Conditions

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: baseline, 2-period, 28 day washout ]

Enrollment: 38
Study Start Date: December 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: protriptyline
    10 mg tablet
    Other Name: Vivactil
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to Protriptyline or any comparable or similar product.
  Contacts and Locations
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): NCT00754962


Locations
United States, New Jersey
Advanced Biomedical Research
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Benno G Roesch, MD Advanced Biomedical Research
  More Information

Responsible Party: Elizabeth Ernst, Director - Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00754962     History of Changes
Other Study ID Numbers: PROT-T10-PVFS-1
First Submitted: September 17, 2008
First Posted: September 18, 2008
Last Update Posted: September 18, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Protriptyline
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs