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

NCT ID: NCT01400165

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Trazodone

Intervention Type: DRUG

each subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic)

Blood Collection

Intervention Type: PROCEDURE

Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.

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

Group Type: ACTIVE_COMPARATOR

Pindolol

Intervention Type: DRUG

each subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic)

Blood Collection

Intervention Type: PROCEDURE

Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.

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

Group Type: ACTIVE_COMPARATOR

Quetiapine

Intervention Type: DRUG

each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)

Blood Collection

Intervention Type: PROCEDURE

Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.

Interventions

Trazodone

each subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic)

Intervention Type: DRUG

Quetiapine

each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)

Intervention Type: DRUG

Pindolol

each subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic)

Intervention Type: DRUG

Blood Collection

Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.

Intervention Type: PROCEDURE

Other Intervention Names

Desyrel; Teva-Trazodone; Seroquel; Teva-Quetiapine; Visken; Teva-Pindolol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ottawa

OTHER

Sponsor Role: lead

Responsible Party

University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit

Principal Investigators

Pierre Blier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit

Franck Chenu, PharmD, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit

Locations

University of Ottawa, Institute of Mental Health Research

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Pierre BLIER, MD, PhD

Role: CONTACT

pierre.blier@rohcg.on.ca

613-722-6521 ext. 6041

Wendy Fusee, RN

Role: CONTACT

wendy.fusee@rohcg.on.ca

613-722-6521 ext. 7828

Facility Contacts

Franck Chenu, PharmD, PhD

Role: primary

franck.chenu@rohcg.on.ca

613-722-6521 ext. 6041

Wendy Fusee, RN

Role: backup

wendy.fusee@rohcg.on.ca

613-722-6521 ext. 7828

Other Identifiers

REB-2010023

Identifier Type: -

Identifier Source: org_study_id