NCT01400165

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Ottawa · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Trazodone	each subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic)
DRUG	Quetiapine	each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)
DRUG	Pindolol	each subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic)
PROCEDURE	Blood Collection	Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-07-22
• Last updated: 2011-07-22

Locations

1 site across 1 country: Canada