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

This study has been completed.
Information provided by:
University of Ottawa Identifier:
First received: May 7, 2008
Last updated: February 10, 2009
Last verified: February 2009
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.

Condition Intervention Phase
Drug: Venlafaxine
Drug: Gen-Citalopram
Drug: Effexor XR
Drug: Celexa
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:

Further study details as provided by University of Ottawa:

Primary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: November 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: Venlafaxine
NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic)
Drug: Effexor XR
Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name)
Active Comparator: 2

Crossover Celexa/Gen-citalopram

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.

Drug: Gen-Citalopram
Gen-Citalopram 40 mg (Genpharm, Generic)
Drug: Celexa
Celexa 40 mg (Lundbeck, Brand Name)


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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)
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Please refer to this study by its identifier: NCT00676039

Canada, Ontario
University of Ottawa, Institute of Mental Health Research
Ottawa, Ontario, Canada, K1Z7K4
Sponsors and Collaborators
University of Ottawa
Study Director: Franck Chenu, Ph.D. University of Ottawa Institute of Mental Health Research
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Pierre BLIER, University of Ottawa, Institute of Mental Health Research Identifier: NCT00676039     History of Changes
Other Study ID Numbers: REB-2007024
Study First Received: May 7, 2008
Last Updated: February 10, 2009

Keywords provided by University of Ottawa:
Therapeutic Equivalency
Human Experimentation
Brand name
Healthy volunteers

Additional relevant MeSH terms:
Antidepressive Agents
Venlafaxine Hydrochloride
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Serotonin Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents processed this record on April 26, 2017