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

Information source: University of Ottawa
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Venlafaxine (Drug); Gen-Citalopram (Drug); Effexor XR (Drug); Celexa (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of Ottawa

Official(s) and/or principal investigator(s):
Franck Chenu, Ph.D., Study Director, Affiliation: University of Ottawa Institute of Mental Health Research

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Blood levels of drugs and their metabolite (when appropriate) will be evaluated for both the generic and the brand name medication.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Healthy volunteers (absence of diseases: psychiatric, physical, neurological,

metabolic,...) Exclusion Criteria:

- Psychiatric disorder

- Hepatic disease

- Renal disease

- Gastrointestinal disease

- Hematological disease

- Smokers

- Physical and/or neurological disease

- Positive urine drug screen

- Abnormal blood pressure

- Abnormal urine/blood analysis (sodium, potassium, chloride, creatinine, urea, ALT,

AST, total protein, glucose, and TSH)

Locations and Contacts

University of Ottawa, Institute of Mental Health Research, Ottawa, Ontario K1Z7K4, Canada
Additional Information

Starting date: November 2007
Last updated: February 10, 2009

Page last updated: August 23, 2015

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