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

Study Overview
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Brief Summary
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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.

Official Title
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Examination of the Pharmacokinetic Properties of Three Generic Medications and Their Respective Brand Preparations in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Trazodone
* Drug: Quetiapine
* Drug: Pindolol
* Procedure: Blood Collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Desyrel/Teva-Trazodone<br>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<br>* each subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic)<br>* Other names: Teva-Trazodone;Procedure: Blood Collection<br>* Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.<br>|
| Active Comparator: Visken/Teva-Pindolol<br>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<br>* each subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic)<br>* Other names: Teva-Pindolol;Procedure: Blood Collection<br>* Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.<br>|
| Active Comparator: Seroquel/Teva-Quetiapine<br>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<br>* each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)<br>* Other names: Teva-Quetiapine;Procedure: Blood Collection<br>* Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of Medication |  | 0 to 48 hours after drug ingestion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic Equivalency, Human Experimentation, Bioequivalence, Brand name, Generic, Healthy volunteers