Title: Pharmacokinetics and bioequivalence of epinastine hydrochloride,a histamine H_1 receptor antagonist,in healthy Chinese volunteers
Abstract: AIM:To determine the pharmacokinetics and bioequivalence of epinastine(EPN)hydrochloride,a promising histamine H1 receptor antagonist,in healthy Chinese volunteers under fasting conditions.METHODS:EPN hydrochloride test and reference tablets were administered as a single dose on two treatment days separated by a 1-week washout period.After dosing,serial blood samples were collected for a period of 36 h,and plasma EPN hydrochloride concentrations were determined by a validated reversed-phase HPLC method and pharmacokinetic parameters were calculated with DAS software.RESULTS:Plasma concentration-time profiles were adequately described by a two-compartment open model.The compound was rapidly absorbed and cleared slowly from plasma with a half-life of approximately 10 h.The main pharmacokinetic parameters of EPN hydrochloride test and reference tablets were as follow:tmax were(2.2±0.5)and(2.0±0.4)h,Cmax were(66±16)and(68±13)μg/L,t1/2 were(10.1±1.3)and(10.4±2.4)h,AUC0-36 were(592±88)and(601±94)μg·h·L-1,respectively.The relative bioavailability of test tablets was(99±13)%.CONCLUSION:The results indicate that the two formulations of EPN hydrochloride tablets are bioequivalent in the rate and extent of absorption.
Publication Year: 2007
Publication Date: 2007-01-01
Language: en
Type: article
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Cited By Count: 1
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