CClinicalTrials.gg
Status unknownNCT01400165Updated Jul 22, 2011

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

A Phase 1 interventional study of Trazodone and Quetiapine in Healthy, sponsored by University of Ottawa. Status unknown at 1 site in Canada. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-22.

Sponsored by University of Ottawa · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

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.

02

Conditions studied

  • Healthy

Keywords

  • Therapeutic Equivalency
  • Human Experimentation
  • Bioequivalence
  • Brand name
  • Generic
  • Healthy volunteers
03

In context

Lead sponsor

University of Ottawa is the lead sponsor of 123 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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 · Procedure: Blood Collection

  • 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

    Drug: Pindolol · Procedure: Blood Collection

  • 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

    Drug: Quetiapine · Procedure: Blood Collection

Interventions

  • DrugTrazodone

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

    Also known as: Desyrel, Teva-Trazodone

  • DrugQuetiapine

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

    Also known as: Seroquel, Teva-Quetiapine

  • DrugPindolol

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

    Also known as: Visken, Teva-Pindolol

  • ProcedureBlood Collection

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

06

What researchers measure

Primary outcomes

  1. Plasma levels of Medication

    Time frame: 0 to 48 hours after drug ingestion

07

Study locations

1 of 1 sites recruiting
  • University of Ottawa, Institute of Mental Health Research
    Ottawa, Ontario K1Z-7K4, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01400165
Lead sponsor
University of Ottawa
First posted
Jul 22, 2011
Start date
Jul 2011
Primary completion
Dec 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Jul 22, 2011

Study contacts

Pierre BLIER, MD, PhD
Contact
pierre.blier@rohcg.on.ca
613-722-6521 ext. 6041
Wendy Fusee, RN
Contact
wendy.fusee@rohcg.on.ca
613-722-6521 ext. 7828
Pierre Blier, MD, PhD
principal investigator · University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit
Franck Chenu, PharmD, Phd
principal investigator · University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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