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Trial record 1 of 2 for:    PROTRIPTYLINE
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Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions

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ClinicalTrials.gov Identifier: NCT00754962
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : January 23, 2018
Sponsor:
Information provided by:
West-Ward Pharmaceutical

Brief Summary:
The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets under fasted conditions

Condition or disease Intervention/treatment Phase
Depression Drug: protriptyline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
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
Study Start Date : December 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: protriptyline
    10 mg tablet
    Other Name: Vivactil


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


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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.

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

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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 Posted: September 18, 2008    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Protriptyline
Depression
Behavioral Symptoms
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