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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: Trazodone; Procedure: Blood Collection; Drug: Pindolol; Drug: Quetiapine

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pierre BLIER, MD, PhD; Phone Number: 6041 613-722-6521; Email: pierre.blier@rohcg.on.ca
• Study Contact Backup: Name: Wendy Fusee, RN; Phone Number: 7828 613-722-6521; Email: wendy.fusee@rohcg.on.ca

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Desyrel/Teva-Trazodone; 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.	Drug: Trazodone; each subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic); Other Names: Desyrel; Teva-Trazodone; Procedure: Blood Collection; Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.
Active Comparator: Visken/Teva-Pindolol; 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	Procedure: Blood Collection; Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.; Drug: Pindolol; each subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic); Other Names: Visken; Teva-Pindolol
Active Comparator: Seroquel/Teva-Quetiapine; 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	Procedure: Blood Collection; Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.; Drug: Quetiapine; each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic); Other Names: Seroquel; Teva-Quetiapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma levels of Medication	0 to 48 hours after drug ingestion

Collaborators and Investigators

• Sponsor: University of Ottawa
• Investigators: Principal Investigator: Pierre Blier, MD, PhD, University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit; Principal Investigator: Franck Chenu, PharmD, Phd, University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: July 21, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 22, 2011

Study Record Updates

• Last Update Posted (Estimate): July 22, 2011
• Last Update Submitted That Met QC Criteria: July 21, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Healthy volunteers; Bioequivalence; Generic; Therapeutic Equivalency; Human Experimentation; Brand name
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antidepressive Agents, Second-Generation; Quetiapine Fumarate; Trazodone; Pindolol
• Other Study ID Numbers: REB-2010023