Bioequivalence of two brands of citalopram 40 mg tablets after single oral administration to healthy volunteers.

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F05%3A00001967" target="_blank" >RIV/61989592:15110/05:00001967 - isvavai.cz</a>

Result on the web

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DOI - Digital Object Identifier

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Result language

angličtina

Original language name

Bioequivalence of two brands of citalopram 40 mg tablets after single oral administration to healthy volunteers.

Original language description

A randomized, two-way, crossover, bioequivalence study was conducted in 26 fasting, healthy, male volunteers tocompare two brands of citalopram 40 mg tablets, Citol (Abdi Ibrahim &#304;laç San. ve Tic A.Ş., Istanbul, Turkey) as a testand Cipramil(R) (H.Lundbeck A/S, Copenhagen, Denmark) as a reference product. One tablet of either formulationwas administered with low-carbonate water after 10 h of overnight fasting. After dosing, serial blood samples werecollected during a period of 24 hours. Plasma samples were analysed for citalopram by a validated HPLC method.The pharmacokinetic parameters AUC0-24, AUC0-&#945;, Cmax, Tmax, Kel, T1/2, and CL were determined from plasma concentration-time pro&#64257;les for both formulations and were compared statistically to evaluate bioequivalence between thetwo brands of citalopram, using the statistical modules recommended by FDA. The analysis of variance (ANOVA)did not show any signi&#64257;cant di&#64256;erence between the two formulations a

Czech name

Bioekvivalence dvou značek citalopramu 40mg tbl. po jedné orální davce na zdravých dobrovolnících.

Czech description

Tato dvojfázová, zkřížená studie založená na opakovaném podávání léku zdravým dobrovolníkům s cílem stanovit bioekvivalenci (podobnost) dvou lékových forem pro perorální (ústní) podání obsahujících 40 mg citalopramu v jedné tabletě, a to Citol (Abdi Ibrahim &#304;laç San. ve Tic A.Ş., Istanbul, Turkey a Cipramil(R) (H. Lundbeck A/S, Copenhagen, Denmark) jako referenční produkt.

Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FR - Pharmacology and apothecary chemistry

OECD FORD branch

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Project

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Continuities

Z - Vyzkumny zamer (s odkazem do CEZ)

Publication year

2005

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Biomedical Papers

ISSN

1213-8118

e-ISSN

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Volume of the periodical

149

Issue of the periodical within the volume

1

Country of publishing house

CZ - CZECH REPUBLIC

Number of pages

4

Pages from-to

169-172

UT code for WoS article

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EID of the result in the Scopus database

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