NCT00676039

Comparison of the Pharmacokinetics of Two Generic Antidepressants and Their Respective Brand Preparations

Examination of the Pharmacokinetic Properties of Two Generic Antidepressants and Their Respective Brand Preparations in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Ottawa · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Venlafaxine	NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic)
DRUG	Gen-Citalopram	Gen-Citalopram 40 mg (Genpharm, Generic)
DRUG	Effexor XR	Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name)
DRUG	Celexa	Celexa 40 mg (Lundbeck, Brand Name)

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-05-12
• Last updated: 2009-02-11

Locations

1 site across 1 country: Canada