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2008•Pharmaceutical Journal of Chinese People's Liberation ArmyRequires access

Pharmacokinetics and Bioequivalence of Cefaclor in Healthy Volunteers

Yan Shi

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Abstract

Aim To study the bioavailability and bioequivalence of Cefaclor in healthy adult volunteers.Methods A randomized crossover design was used.Twenty healthy adult volunteers received a single oral dosage of 500mg of test preparation and reference preparation.Blood samples were collected at different time points and the plasma concentration of Cefalor was measured by High Performance Liquid Chromatography(HPLC) method,and main pharmacokinetic parameters calculated.Results For the test preparation of Cefaclor,t1/2 was(0.931±0.247)h、 Cmax(6.654±1.378)μg·ml-1,Tmax(0.775±0.138)h,AUC0-t(10.038±2.074)μg·h·ml-1 while for the reference preparation of Cefaclor t1/2 was(0.888±0.218)h,Cmax(6.895±1.326)μg·ml-1,Tmax(0.725 ±0.138)h,AUC0-t(10.175±2.544)μg·h·ml-1.The average relative bioavailability was(100.3±9.5)% according to AUC0-t.Conclusion The two kinds of preparation are bioequivalent.

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What this paper is about

Aim To study the bioavailability and bioequivalence of Cefaclor in healthy adult volunteers.Methods A randomized crossover design was used.Twenty healthy adult volunteers received a single oral dosage of 500mg of test preparation and reference preparation.Blood samples were collected at different time points and the plasma concentration of Cefalor was measured by High Performance Liquid Chromatography(HPLC) method,and main pharmacokinetic parameters calculated.Results For the test preparation of Cefaclor,t1/2 was(0.931±0.247)h、 Cmax(6.654±1.378)μg·ml-1,Tmax(0.775±0.138)h,AUC0-t(10.038±2.074)μg·h·ml-1 while for the reference preparation of Cefaclor t1/2 was(0.888±0.218)h,Cmax(6.895±1.326)μg·ml-1,Tmax(0.725 ±0.138)h,AUC0-t(10.175±2.544)μg·h·ml-1.The average relative bioavailability was(100.3±9.5)% according to AUC0-t.Conclusion The two kinds of preparation are bioequivalent.

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Available abstract

Aim To study the bioavailability and bioequivalence of Cefaclor in healthy adult volunteers.Methods A randomized crossover design was used.Twenty healthy adult volunteers received a single oral dosage of 500mg of test preparation and reference preparation.Blood samples were collected at different time points and the plasma concentration of Cefalor was measured by High Performance Liquid Chromatography(HPLC) method,and main pharmacokinetic parameters calculated.Results For the test preparation of Cefaclor,t1/2 was(0.931±0.247)h、 Cmax(6.654±1.378)μg·ml-1,Tmax(0.775±0.138)h,AUC0-t(10.038±2.074)μg·h·ml-1 while for the reference preparation of Cefaclor t1/2 was(0.888±0.218)h,Cmax(6.895±1.326)μg·ml-1,Tmax(0.725 ±0.138)h,AUC0-t(10.175±2.544)μg·h·ml-1.The average relative bioavailability was(100.3±9.5)% according to AUC0-t.Conclusion The two kinds of preparation are bioequivalent.

Key concepts: Bioequivalence, Cefaclor, Cmax, Bioavailability, Pharmacokinetics, High-performance liquid chromatography, Crossover study, Pharmacology

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