We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of the Pharmacokinetics of Three Generic Medications and Their Respective Brand Preparations

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by University of Ottawa.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01400165
First Posted: July 22, 2011
Last Update Posted: July 22, 2011
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:
University of Ottawa
  Purpose
Generic describes a pharmaceutical product that does not have a brand name or trademark. Generic medications should be the equivalent of brand medications. Only their price should be different. The active ingredient of the generic medication has to be within a window of 80 to 125% of the original in the blood. There are reports that this standard is not always followed after the medication has been on the market. Indeed, it was observed that some patients previously stable on original medications relapsed when switched to a generic. Several factors could account for this problem. Such problems have been reported for Pindolol, Quetiapine, and Trazodone. Some properties of specific brands of the generics and the original brands will be examined for these three medications. The three original medications used in this study are the Visken, the Seroquel, and the Desyrel. The three generics are the Teva-pindolol, the Teva-Quetiapine, and the Teva-Trazodone. They are all available on the Canadian market by prescription.

Condition Intervention Phase
Healthy Drug: Trazodone Drug: Quetiapine Drug: Pindolol Procedure: Blood Collection Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examination of the Pharmacokinetic Properties of Three Generic Medications and Their Respective Brand Preparations in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by University of Ottawa:

Primary Outcome Measures:
  • Plasma levels of Medication [ Time Frame: 0 to 48 hours after drug ingestion ]

Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Desyrel/Teva-Trazodone
Both drugs will be given at the dose of 150 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication.
Drug: Trazodone
each subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic)
Other Names:
  • Desyrel
  • Teva-Trazodone
Procedure: Blood Collection
Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.
Active Comparator: Visken/Teva-Pindolol
Both drugs will be given at the dose of 10 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication
Drug: Pindolol
each subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic)
Other Names:
  • Visken
  • Teva-Pindolol
Procedure: Blood Collection
Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.
Active Comparator: Seroquel/Teva-Quetiapine
Both drugs will be given at the dose of 100 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication
Drug: Quetiapine
each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)
Other Names:
  • Seroquel
  • Teva-Quetiapine
Procedure: Blood Collection
Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)

Exclusion Criteria:

  • Psychiatric disorder
  • Hepatic disease
  • Renal disease
  • Gastrointestinal disease
  • Hematological disease
  • Smokers
  • Physical and/or neurological disease
  • Positive urine drug screen
  • Abnormal blood pressure
  • Abnormal Electrocardiogram
  • Abnormal urine/blood analysis (sodium, potassium, chloride, creatinine, urea, ALT, AST, total protein, glucose, and TSH)
  • Taking medication
  • Have donated 50 mL to 499 mL whole blood within 30 days and more than 499 mL whole blood within 56 days preceding entry into this study
  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): NCT01400165


Contacts
Contact: Pierre BLIER, MD, PhD 613-722-6521 ext 6041 pierre.blier@rohcg.on.ca
Contact: Wendy Fusee, RN 613-722-6521 ext 7828 wendy.fusee@rohcg.on.ca

Locations
Canada, Ontario
University of Ottawa, Institute of Mental Health Research Recruiting
Ottawa, Ontario, Canada, K1Z-7K4
Contact: Franck Chenu, PharmD, PhD    613-722-6521 ext 6041    franck.chenu@rohcg.on.ca   
Contact: Wendy Fusee, RN    613-722-6521 ext 7828    wendy.fusee@rohcg.on.ca   
Sponsors and Collaborators
University of Ottawa
Investigators
Principal Investigator: Pierre Blier, MD, PhD University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit
Principal Investigator: Franck Chenu, PharmD, Phd University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit
  More Information

Responsible Party: Dr Pierre BLIER, MD, PhD, University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit
ClinicalTrials.gov Identifier: NCT01400165     History of Changes
Other Study ID Numbers: REB-2010023
First Submitted: July 21, 2011
First Posted: July 22, 2011
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by University of Ottawa:
Therapeutic Equivalency
Human Experimentation
Bioequivalence
Brand name
Generic
Healthy volunteers

Additional relevant MeSH terms:
Quetiapine Fumarate
Trazodone
Pindolol
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anti-Anxiety Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Antihypertensive Agents
Serotonin Antagonists
Vasodilator Agents