Bioequivalence evaluation of two brands of ketoconazole tablets (Onofin-K and Nizoral) in a healthy female Mexican population

Marcelín Jiménez G

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Título :	Bioequivalence evaluation of two brands of ketoconazole tablets (Onofin-K and Nizoral) in a healthy female Mexican population
Creador:	Marcelín Jiménez G
Nivel de acceso:	Open access
Palabras clave :	Equivalencia Terapéutica Química Farmacéutica Intervalos de Confianza Estudios cruzados Cetoconazol - Sangre Cetoconazol - farmacocinetica Comprimidos recubiertos Analysis of Variance Chemistry, Pharmaceutical Confidence Intervals Cross-Over Studies Ketoconazole - blood Ketoconazole - pharmacokinetics Tablets, Enteric-Coated Therapeutic Equivalency Cetoconazol Equivalencia Terapéutica ketoconazole bioequivalence HPLC Pharmacokinetics
Descripción :	A randomized, crossover study was conducted in 24 healthy female volunteers tocompare the bioavailability of two brands of ketoconazole (200 mg) tablets; Onofin-K1(Farm-ace´uticos Rayere S.A., Me´xico) as the test and NIZORAL1(Janssen-Cilag, Me´xico) as the referenceproducts. The study was performed at the Clinical Pharmacology Research Center of the HospitalGeneral de Me´xico in Mexico City. Two tablets (400 mg) were administered as a single dose with250 ml of water after a 12 h overnight fast on two treatment days separated by a 1 week washoutperiod. After dosing, serial blood samples were collected for a period of 12 h. Plasma harvested wasanalysed for ketoconazole by a modified and validated HPLC method with UV detection in therange 400–14000 ng/ml, using 200 ml of plasma in a full-run time of 2.5 min. The pharmacokineticparameters AUC0t, AUC0a, Cmax, Tmaxand t1/2were determined from plasma concentrations ofboth formulations and the results discussed. AUC0t, AUC0aand Cmaxwere tested for bio-equivalence after log transformation of data, and no significant differences were found either in90% classic confidence interval or in the Anderson and Hauck test (p50:05). Based on statisticalanalysis, it is concluded that Onofin-K1is bioequivalent to Nizoral1. Copyright # 2004 JohnWiley & Sons, Ltd.
Colaborador(es) u otros Autores:	Hernández J Angeles AP Contreras L Hinojosa M Rivera L Martínez Rossier L Amanci José Hernández Alionka P Angeles L Contreras Hinojosa M Rivera L Martínez Rossier L Amancio O Fernándezo O A Fernández A
Fecha de publicación :	2004
Tipo de publicación:	Artículo
Formato:	pdf
Identificador del Recurso :	10.1002/bdd.399
Fuente:	Biopharmaceutics & Drug Disposition 25(5):203-209
URI :	http://repositorio.pediatria.gob.mx:8180/handle/20.500.12103/2116
Idioma:	eng
Aparece en las colecciones:	Artículos

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