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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of Ottawa.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Ottawa
ClinicalTrials.gov Identifier:
NCT01400165
First received: July 21, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
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: 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

No publications provided

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
Study First Received: July 21, 2011
Last Updated: July 21, 2011
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on July 23, 2014