Healthy | Comparison of the Pharmacokinetics of Three Generic Medications and Their Respective Brand Preparations
Healthy research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Trazodoneeach subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic)
Drug:Quetiapineeach subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)
Drug:Pindololeach subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic)
Procedure:Blood CollectionBlood Samples will be collected at a predefined time-frame to study the plasma level of each medication.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Desyrel/Teva-TrazodoneBoth 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.
Visken/Teva-PindololBoth 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
Seroquel/Teva-QuetiapineBoth 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
Start Date: July 2011
Completed Date: December 2011
Phase: Phase 1
Primary Outcome: Plasma levels of Medication
Study sponsors, principal investigator, and references
Principal Investigator: Pierre Blier, MD, PhD
Lead Sponsor: University of Ottawa