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

NCT00676039 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2009-02-11

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • University of Ottawa

    lead OTHER

Principal Investigators

  • Franck Chenu, Ph.D. · University of Ottawa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00676039 on ClinicalTrials.gov