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OpenTrials
Completed

NCT Number: NCT00676039

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of Ottawa, Institute of Mental Health Research

Ottawa, Ontario, K1Z7K4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Venlafaxine

Drug

NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic)

Gen-Citalopram

Drug

Gen-Citalopram 40 mg (Genpharm, Generic)

Effexor XR

Drug

Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name)

Celexa

Drug

Celexa 40 mg (Lundbeck, Brand Name)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Ottawa

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 12, 2008
Registry last updated
Feb 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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