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

NCT00676039 | Completed Phase 1

• 1 other identifier: REB-2007024
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Therapeutic Equivalency; Human Experimentation; Bioequivalence; Brand name; Generic; Antidepressant; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

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

  1 month

Study Arms (2)

1

ACTIVE COMPARATOR

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; Drug: Effexor XR

2

ACTIVE COMPARATOR

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; Drug: Celexa

Interventions

Venlafaxine DRUG

NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic)

1

Gen-Citalopram DRUG

Gen-Citalopram 40 mg (Genpharm, Generic)

2

Effexor XR DRUG

Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name)

1

Celexa DRUG

Celexa 40 mg (Lundbeck, Brand Name)

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa, Institute of Mental Health Research

Ottawa, Ontario, K1Z7K4, Canada

Location

Related Publications (1)

• Chenu F, Batten LA, Zernig G, Ladstaetter E, Hebert C, Blier P. Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study. J Clin Psychiatry. 2009 Jul;70(7):958-66. doi: 10.4088/jcp.09m05315.

  PMID: 19653973 DERIVED

MeSH Terms

Interventions

Venlafaxine Hydrochloride; Citalopram

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Franck Chenu, Ph.D.

  University of Ottawa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 12, 2008
• Study Start: November 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 11, 2009

Record last verified: 2009-02

Locations

CA (1)