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

Information source: University of Ottawa
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Trazodone (Drug); Quetiapine (Drug); Pindolol (Drug); Blood Collection (Procedure)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Ottawa

Official(s) and/or principal investigator(s):
Pierre Blier, MD, PhD, Principal Investigator, Affiliation: University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit
Franck Chenu, PharmD, Phd, Principal Investigator, Affiliation: University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit

Overall contact:
Pierre BLIER, MD, PhD, Phone: 613-722-6521, Ext: 6041, Email: pierre.blier@rohcg.on.ca

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Plasma levels of Medication

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

Pierre BLIER, MD, PhD, Phone: 613-722-6521, Ext: 6041, Email: pierre.blier@rohcg.on.ca

University of Ottawa, Institute of Mental Health Research, Ottawa, Ontario K1Z-7K4, Canada; Recruiting
Franck Chenu, PharmD, PhD, Phone: 613-722-6521, Ext: 6041, Email: franck.chenu@rohcg.on.ca
Wendy Fusee, RN, Phone: 613-722-6521, Ext: 7828, Email: wendy.fusee@rohcg.on.ca
Additional Information

Starting date: July 2011
Last updated: July 21, 2011

Page last updated: August 23, 2015

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