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Seroquel/Teva-Quetiapine for Healthy Subjects

Phase 1
Waitlist Available
Led By Pierre Blier, MD, PhD
Research Sponsored by University of Ottawa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 48 hours after drug ingestion
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 48 hours after drug ingestion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 48 hours after drug ingestion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma levels of Medication

Trial Design

3Treatment groups
Active Control
Group I: Seroquel/Teva-QuetiapineActive Control2 Interventions
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 II: Visken/Teva-PindololActive Control2 Interventions
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 III: Desyrel/Teva-TrazodoneActive Control2 Interventions
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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of OttawaLead Sponsor
208 Previous Clinical Trials
267,126 Total Patients Enrolled
Pierre Blier, MD, PhDPrincipal InvestigatorUniversity of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit
1 Previous Clinical Trials
240 Total Patients Enrolled
Franck Chenu, PharmD, PhdPrincipal InvestigatorUniversity of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby May 2025