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

University of Ottawa

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Procedure: Blood Collection; Drug: Quetiapine; Drug: Pindolol; Drug: Trazodone

Study type: Interventional

Funder types: Other

Identifiers

NCT01400165

REB-2010023

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Desyrel/Teva-Trazodone

Active Comparator group

Description:

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.

Treatment:

Procedure: Blood Collection

Drug: Trazodone

Visken/Teva-Pindolol

Active Comparator group

Description:

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

Treatment:

Procedure: Blood Collection

Drug: Pindolol

Seroquel/Teva-Quetiapine

Active Comparator group

Description:

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

Treatment:

Procedure: Blood Collection

Drug: Quetiapine