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

This study has been completed.
Sponsor:
Information provided by:
University of Ottawa
ClinicalTrials.gov Identifier:
NCT00676039
First received: May 7, 2008
Last updated: February 10, 2009
Last verified: February 2009
History of Changes
  Purpose

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
Healthy
 Drug: Venlafaxine
Drug: Gen-Citalopram
Drug: Effexor XR
Drug: Celexa
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
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:

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676039

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

No publications provided by University of Ottawa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Pierre BLIER, University of Ottawa, Institute of Mental Health Research
ClinicalTrials.gov Identifier: NCT00676039     History of Changes
Other Study ID Numbers: REB-2007024
Study First Received: May 7, 2008
Last Updated: February 10, 2009
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Antidepressive Agents
Citalopram
Venlafaxine
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 22, 2013