Healthy
Conditions
Keywords
Therapeutic Equivalency, Human Experimentation, Bioequivalence, Brand name, Generic, Healthy volunteers
Brief 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.
Interventions
DRUGTrazodone
each subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic)
DRUGQuetiapine
each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)
DRUGPindolol
each subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic)
PROCEDUREBlood Collection
Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.
Sponsors
University of Ottawa
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma levels of Medication | 0 to 48 hours after drug ingestion |
Countries
Canada
Contacts
Primary ContactPierre BLIER, MD, PhD
Backup ContactWendy Fusee, RN
Outcome results
None listed