Comparison of the Pharmacokinetics of Two Generic Antidepressants and Their Respective Brand Preparations
Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
Participant gender:
Summary
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.