Comparison of the Pharmacokinetics of Two Generic Antidepressants and Their Respective Brand Preparations
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.
Drug: Effexor XR
|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 Two Generic Antidepressants and Their Respective Brand Preparations in Healthy Male Volunteers|
- Blood levels of drugs and their metabolite (when appropriate) will be evaluated for both the generic and the brand name medication. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
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.
NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic)Drug: Effexor XR
Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name)
Active Comparator: 2
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.
Gen-Citalopram 40 mg (Genpharm, Generic)Drug: Celexa
Celexa 40 mg (Lundbeck, Brand Name)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676039
|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|