Comparison of the Pharmacokinetics of Two Generic Antidepressants and Their Respective Brand Preparations
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|ClinicalTrials.gov Identifier: NCT00676039|
Recruitment Status : Completed
First Posted : May 12, 2008
Last Update Posted : February 11, 2009
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Venlafaxine Drug: Gen-Citalopram Drug: Effexor XR Drug: Celexa||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Examination of the Pharmacokinetic Properties of Two Generic Antidepressants and Their Respective Brand Preparations in Healthy Male Volunteers|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
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.
NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic)
Drug: Effexor XR
Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name)
Active Comparator: 2
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.
Gen-Citalopram 40 mg (Genpharm, Generic)
Celexa 40 mg (Lundbeck, Brand Name)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676039
|University of Ottawa, Institute of Mental Health Research|
|Ottawa, Ontario, Canada, K1Z7K4|
|Study Director:||Franck Chenu, Ph.D.||University of Ottawa Institute of Mental Health Research|