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

July 21, 2011
July 21, 2011
July 2011
December 2011   (final data collection date for primary outcome measure)
Plasma levels of Medication [ Time Frame: 0 to 48 hours after drug ingestion ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of the Pharmacokinetics of Three Generic Medications and Their Respective Brand Preparations
Examination of the Pharmacokinetic Properties of Three Generic Medications and Their Respective Brand Preparations in Healthy Male Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Trazodone
    each subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic)
    Other Names:
    • Desyrel
    • Teva-Trazodone
  • Drug: Quetiapine
    each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)
    Other Names:
    • Seroquel
    • Teva-Quetiapine
  • 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: 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.
    Interventions:
    • Drug: Trazodone
    • Procedure: Blood Collection
  • 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
    Interventions:
    • Drug: Pindolol
    • Procedure: Blood Collection
  • 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
    Interventions:
    • Drug: Quetiapine
    • Procedure: Blood Collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
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
Canada
 
NCT01400165
REB-2010023
No
Dr Pierre BLIER, MD, PhD, University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit
University of Ottawa
Not Provided
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
University of Ottawa
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP