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

NCT01400165 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-07-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Ottawa

    lead OTHER

Principal Investigators

  • Pierre Blier, MD, PhD · University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit

  • Franck Chenu, PharmD, Phd · University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400165 on ClinicalTrials.gov