Comparison of the Pharmacokinetic of Two Generic Antidepressants and Their Respective Brand Preparations
Information source: University of Ottawa
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Therapeutic Equivalency; Human Experimentation
Intervention: Venlafaxine (Drug); Citalopram (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Ottawa Overall contact:
Pierre Blier, MD, Phone: 613-722-6521, Ext: 6908, Email: pierre.blier@rohcg.on.ca
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: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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
Pierre Blier, MD, Phone: 613-722-6521, Ext: 6908, Email: pierre.blier@rohcg.on.ca
University of Ottawa, Institute of Mental Health Research, OTTAWA, Ontario K1Z7K4, Canada; Recruiting
Chantal Hebert, RN, Phone: 613-722-6521, Ext: 6217, Email: chantal.hebert@rohcg.on.ca
Additional Information
Starting date: November 2007
Ending date: July 2008
Last updated: May 7, 2008
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