Comparison of the Pharmacokinetics of Three Generic Medications and Their Respective Brand Preparations
Information source: University of Ottawa
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Trazodone (Drug); Quetiapine (Drug); Pindolol (Drug); Blood Collection (Procedure)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Ottawa Official(s) and/or principal investigator(s): Pierre Blier, MD, PhD, Principal Investigator, Affiliation: University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit Franck Chenu, PharmD, Phd, Principal Investigator, Affiliation: University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit
Overall contact: Pierre BLIER, MD, PhD, Phone: 613-722-6521, Ext: 6041, Email: pierre.blier@rohcg.on.ca
Summary
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.
Clinical Details
Official title: Examination of the Pharmacokinetic Properties of Three Generic Medications and Their Respective Brand Preparations in Healthy Male Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Plasma levels of Medication
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
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
Locations and Contacts
Pierre BLIER, MD, PhD, Phone: 613-722-6521, Ext: 6041, Email: pierre.blier@rohcg.on.ca
University of Ottawa, Institute of Mental Health Research, Ottawa, Ontario K1Z-7K4, Canada; Recruiting Franck Chenu, PharmD, PhD, Phone: 613-722-6521, Ext: 6041, Email: franck.chenu@rohcg.on.ca Wendy Fusee, RN, Phone: 613-722-6521, Ext: 7828, Email: wendy.fusee@rohcg.on.ca
Additional Information
Starting date: July 2011
Last updated: July 21, 2011
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