drugset / Trial / NCT01400165

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

NCT01400165

Phase 1 Unknown 30 enrolled University of Ottawa
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2011-07
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pindolol Small molecule 10 mg
Comparator Quetiapine Small molecule 100 mg
Comparator Trazodone Small molecule 150 mg

Indications

No indication recorded.