Comparison of the Pharmacokinetics of Three Generic Medications and Their Respective Brand Preparations
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Trazodone Drug: Quetiapine Drug: Pindolol Procedure: Blood Collection |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Examination of the Pharmacokinetic Properties of Three Generic Medications and Their Respective Brand Preparations in Healthy Male Volunteers |
- Plasma levels of Medication [ Time Frame: 0 to 48 hours after drug ingestion ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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
|
Drug: Pindolol
each subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic)
Other Names:
Procedure: Blood Collection
Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.
|
|
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
each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)
Other Names:
Procedure: Blood Collection
Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Pierre BLIER, MD, PhD | 613-722-6521 ext 6041 | pierre.blier@rohcg.on.ca |
| Contact: Wendy Fusee, RN | 613-722-6521 ext 7828 | wendy.fusee@rohcg.on.ca |
| Canada, Ontario | |
| University of Ottawa, Institute of Mental Health Research | Recruiting |
| Ottawa, Ontario, Canada, K1Z-7K4 | |
| Contact: Franck Chenu, PharmD, PhD 613-722-6521 ext 6041 franck.chenu@rohcg.on.ca | |
| Contact: Wendy Fusee, RN 613-722-6521 ext 7828 wendy.fusee@rohcg.on.ca | |
| 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 |
More Information
No publications provided
| Responsible Party: | Dr Pierre BLIER, MD, PhD, University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit |
| ClinicalTrials.gov Identifier: | NCT01400165 History of Changes |
| Other Study ID Numbers: | REB-2010023 |
| Study First Received: | July 21, 2011 |
| Last Updated: | July 21, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Ottawa:
|
Therapeutic Equivalency Human Experimentation Bioequivalence |
Brand name Generic Healthy volunteers |
Additional relevant MeSH terms:
|
Trazodone Quetiapine Pindolol Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antidepressive Agents, Second-Generation Antidepressive Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Antihypertensive Agents Cardiovascular Agents Serotonin Antagonists Vasodilator Agents Antipsychotic Agents |
ClinicalTrials.gov processed this record on May 23, 2013