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Studies on Pharmacokinetics and Relative Bioavailability of Two Kinds of Cefaclor Capsule in Healthy Volunteers

Dong Won Chun

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Abstract

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of two kinds of cefaclor capsule in healthy volunteersMETHODS:Plasma cefaclor concentrations were measured with HPLC methodEach subject was administered with a single oral dose of domestic or imported cefaclor capsule(500mg)in a randomized crossover studyRESULTS:Plasma concentration-time curves of domestic and imported cefaclor capsules fitted to a one-compartment open model with a first order absorptionThe peak plasma levels(Cmax)averaged(1324±242)and (1329±314)μg/ml,times to reach the peak level(Tmax)were (058±0192)and(055±010)h,the elimination half lives(T1/2)were (042±009)and(041±009)h,the areas under the plasma concentration-time curve(AUC0~T)were (1581±153)and(1568±197)h/(μg·ml)respectivelyCONCLUSION:The results of statistical analysis showed that the two formulations were bioequivalentThe relative bioavailability of domestic capsule was(10084±778)%

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OBJECTIVE:To study the pharmacokinetics and relative bioavailability of two kinds of cefaclor capsule in healthy volunteersMETHODS:Plasma cefaclor concentrations were measured with HPLC methodEach subject was administered with a single oral dose of domestic or imported cefaclor capsule(500mg)in a randomized crossover studyRESULTS:Plasma concentration-time curves of domestic and imported cefaclor capsules fitted to a one-compartment open model with a first order absorptionThe peak plasma levels(Cmax)averaged(1324±242)and (1329±314)μg/ml,times to reach the peak level(Tmax)were (058±0192)and(055±010)h,the elimination half lives(T1/2)were (042±009)and(041±009)h,the areas under the plasma concentration-time curve(AUC0~T)were (1581±153)and(1568±197)h/(μg·ml)respectivelyCONCLUSION:The results of statistical analysis showed that the two formulations were bioequivalentThe relative bioavailability of domestic capsule was(10084±778)%

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Available abstract

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of two kinds of cefaclor capsule in healthy volunteersMETHODS:Plasma cefaclor concentrations were measured with HPLC methodEach subject was administered with a single oral dose of domestic or imported cefaclor capsule(500mg)in a randomized crossover studyRESULTS:Plasma concentration-time curves of domestic and imported cefaclor capsules fitted to a one-compartment open model with a first order absorptionThe peak plasma levels(Cmax)averaged(1324±242)and (1329±314)μg/ml,times to reach the peak level(Tmax)were (058±0192)and(055±010)h,the elimination half lives(T1/2)were (042±009)and(041±009)h,the areas under the plasma concentration-time curve(AUC0~T)were (1581±153)and(1568±197)h/(μg·ml)respectivelyCONCLUSION:The results of statistical analysis showed that the two formulations were bioequivalentThe relative bioavailability of domestic capsule was(10084±778)%

Key concepts: Cefaclor, Bioavailability, Capsule, Pharmacokinetics, Cmax, Crossover study, Chemistry, Plasma concentration

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