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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venlafaxine | Drug | NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of drugs and their metabolite (when appropriate) will be evaluated for both the generic and the brand name medication. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franck Chenu, Ph.D. | University of Ottawa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa, Institute of Mental Health Research | Ottawa | Ontario | K1Z7K4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19653973 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 3, 2010 | |
| Reset | Dec 3, 2010 | |
| Release | Jan 18, 2011 | |
| Reset | Feb 14, 2011 | |
| Release | Aug 3, 2011 | |
| Reset | Sep 6, 2011 | |
| Release | Dec 10, 2013 | |
| Reset | Jan 28, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 3, 2010 | Dec 3, 2010 | |||
| Jan 18, 2011 |
| ID | Term |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| 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) |
|
| Feb 14, 2011 |
| Aug 3, 2011 | Sep 6, 2011 |
| Dec 10, 2013 | Jan 28, 2014 |
| Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
| D011437 | Propylamines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |