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Sponsored by: |
University of Ottawa |
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Information provided by: | University of Ottawa |
ClinicalTrials.gov Identifier: | NCT00676039 |
Generic medications should be the equivalent of brand medications with the exception of their price. Before a generic medication is introduced, its bioequivalence within a window of 80 to 125% of the original has to be demonstrated. There are reports that this criterion is not always followed in post-marketed periods. Such investigations were triggered by the observation that some patients previously stable on original medications relapsed when switched to a presumable equivalent generic. Several factors could account for this problem. Given reports of such problems occurring with the antidepressants citalopram and venlafaxine, some pharmacokinetic properties of specific brands of generics and the originals will be examined for these two medications. Twelve healthy male volunteers will participate in this crossover study. It is anticipated that there will be significant differences emerging between the two formulations given the clinical reports of patients deteriorating when switched from the original to the generic preparations.
Condition | Intervention | Phase |
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Healthy |
Drug: Venlafaxine Drug: Gen-Citalopram Drug: Effexor XR Drug: Celexa |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Examination of the Pharmacokinetic Properties of Two Generic Antidepressants and Their Respective Brand Preparations in Healthy Male Volunteers |
Enrollment: | 18 |
Study Start Date: | November 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Crossover Effexor / NOVO-Venlafaxine Examination of the bioequivalence of Effexor (Wyeth Pharmaceuticals) and NOVO-Venlafaxine (NOVOPHARM). Both drugs will be given at the dose of 75 mg/day (one capsule per day) for 4 consecutive days. A washout period (corresponding to 10 half-life of the active metabolite desmethylvenlafaxine) will be respected after receiving each medication. |
Drug: Venlafaxine
NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic)
Drug: Effexor XR
Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name)
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2: Active Comparator
Crossover Celexa/Gen-citalopram Examination of the bioequivalence of Celexa (Lundbeck, Brand Name) and Gen-Citalopram (Genpharm, Generic). Both drugs will be given at the dose of 40 mg/day (one tablet per day) for 8 consecutive days. A washout period (corresponding to 10 half-life of citalopram) will be respected after receiving each medication. |
Drug: Gen-Citalopram
Gen-Citalopram 40 mg (Genpharm, Generic)
Drug: Celexa
Celexa 40 mg (Lundbeck, Brand Name)
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
University of Ottawa, Institute of Mental Health Research | |
OTTAWA, Ontario, Canada, K1Z7K4 |
Study Director: | Franck Chenu, Ph.D. | University of Ottawa Institute of Mental Health Research |
Responsible Party: | University of Ottawa, Institute of Mental Health Research ( Dr Pierre BLIER ) |
Study ID Numbers: | REB-2007024 |
Study First Received: | May 7, 2008 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00676039 |
Health Authority: | Canada: Health Canada |
Therapeutic Equivalency Human Experimentation Bioequivalence Brand name |
Generic Antidepressant Healthy volunteers |
Baclofen Venlafaxine Healthy |
Dexetimide Citalopram Serotonin |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Antidepressive Agents, Second-Generation Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |