University of Ottawa, Institute of Mental Health Research
Ottawa, Ontario, K1Z7K4, Canada
NCT Number: 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.
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Notify Me18 year–50 year
Male
Interventional
Phase 1
Ottawa, Ontario, K1Z7K4, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic)
Gen-Citalopram 40 mg (Genpharm, Generic)
Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name)
Celexa 40 mg (Lundbeck, Brand Name)
Time frame: 1 month
University of Ottawa
Other
Examination of the Pharmacokinetic Properties of Two Generic Antidepressants and Their Respective Brand Preparations in Healthy Male Volunteers
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