HealthyPhase 1NCT01400165
Comparison of the Pharmacokinetics of Three Generic Medications and Their Respective Brand Preparations
A Phase 1 study testing Trazodone, Quetiapine and Pindolol in people with Healthy, run by University of Ottawa at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Trazodone, Quetiapine and Pindolol
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)
Who cannot join
- Psychiatric disorder
- Hepatic disease
- Renal disease
- Gastrointestinal disease
- Hematological disease
- Smokers
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa, Institute of Mental Health Research
Ottawa, Ontario, K1Z-7K4
Franck Chenu, PharmD, PhD, 613-722-6521 ext. 6041, franck.chenu@rohcg.on.ca
Wendy Fusee, RN, 613-722-6521 ext. 7828, wendy.fusee@rohcg.on.ca
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Trazodone, Quetiapine, Pindolol, Blood Collection
- Keywords
- Therapeutic Equivalency, Human Experimentation, Bioequivalence, Brand name, Generic, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrazodoneDrug
Also called Desyrel, Teva-Trazodone
each subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic)
QuetiapineDrug
Also called Seroquel, Teva-Quetiapine
each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)
PindololDrug
Also called Visken, Teva-Pindolol
each subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic)
Blood CollectionProcedure or surgery
Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.
| Study group | Role | What they receive |
|---|---|---|
| Desyrel/Teva-Trazodone | Active comparator | 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. Receives: Drug: Trazodone; Procedure: Blood Collection |
| Visken/Teva-Pindolol | Active comparator | 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 Receives: Drug: Pindolol; Procedure: Blood Collection |
| Seroquel/Teva-Quetiapine | Active comparator | 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 Receives: Drug: Quetiapine; Procedure: Blood Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of Medication
Measured: 0 to 48 hours after drug ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Investigators
- Pierre Blier, MD, PhD, Principal investigator, University of Ottawa, Institute of Mental Health Research - Mood Disorders Research UnitFranck Chenu, PharmD, Phd, Principal investigator, University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400165
- Sponsor's protocol ID
- REB-2010023
- Status last verified
- Jul 2011
- First submitted
- 21 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Pharmacokinetic Properties of Three Generic Medications and Their Respective Brand Preparations in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01400165
- Acronym / sponsor ID
- REB-2010023
- Conditions
- Healthy
- Keywords
- Therapeutic Equivalency, Human Experimentation, Bioequivalence, Brand name, Generic, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Desyrel/Teva-Trazodone | Active comparator | Drug: Trazodone, Procedure: Blood CollectionBoth 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. |
| Visken/Teva-Pindolol | Active comparator | Drug: Pindolol, Procedure: Blood CollectionBoth 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 |
| Seroquel/Teva-Quetiapine | Active comparator | Drug: Quetiapine, Procedure: Blood CollectionBoth 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)
Key exclusion criteria (13 listed)
- Psychiatric disorder
- Hepatic disease
- Renal disease
- Gastrointestinal disease
- Hematological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrazodoneAlso: Desyrel, Teva-Trazodoneeach subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic) | Drug | Desyrel/Teva-Trazodone |
| QuetiapineAlso: Seroquel, Teva-Quetiapineeach subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic) | Drug | Seroquel/Teva-Quetiapine |
| PindololAlso: Visken, Teva-Pindololeach subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic) | Drug | Visken/Teva-Pindolol |
| Blood CollectionBlood Samples will be collected at a predefined time-frame to study the plasma level of each medication. | Procedure or surgery | Desyrel/Teva-Trazodone, Seroquel/Teva-Quetiapine, Visken/Teva-Pindolol |
Primary outcome
Plasma levels of Medication
Time frame: 0 to 48 hours after drug ingestion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trazodone, Quetiapine and Pindolol in people with Healthy, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre BLIER, MD, PhD (613-722-6521 ext. 6041, pierre.blier@rohcg.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of Medication (time frame: 0 to 48 hours after drug ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011.