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2009•Journal of Shenyang Medical CollegeRequires access

Pharmacokinetics and Bioequivalence of Rifapentin Capsules in Healthy Volunteers

Yue Wang

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Abstract

Objective:To study the pharmacokinetics and bioequivalence of Rifapentin capsules in healthy volunteers.Methods:A single oral dose(0.6g tested and reference formulation)was given to 20 healthy volunteers according to an open randomized crossover design.Rifapentin concentration of plasma was determined by HPLC-UV.The pharmacokinetics parameters were calculated and the bioavailability and bioequivalence of two formulation were evaluated by DAS2.0 program.Results:The main pharmacokinetic parameters of Rifapentin were as follows:tmax were (4.700±2.364)and(4.700±1.750)h,t1/2were (16.215±2.356)and(16.825±4.595)h,Cmax were(11.774±5.134)and(10.771±4.868)mg·h·L-1;AUC0-twere(346.539±160.580)and(322.286±147.345)mg·h·L-1;AUC0-∞were(363.137±167.807)and(339.309±154.212)mg·h·L-1.The relative bioavailability of drug was(110.5±25.6)%.Conclusion:The two Rifapentin formulations are bioequivalent.

About this research paper

What this paper is about

Objective:To study the pharmacokinetics and bioequivalence of Rifapentin capsules in healthy volunteers.Methods:A single oral dose(0.6g tested and reference formulation)was given to 20 healthy volunteers according to an open randomized crossover design.Rifapentin concentration of plasma was determined by HPLC-UV.The pharmacokinetics parameters were calculated and the bioavailability and bioequivalence of two formulation were evaluated by DAS2.0 program.Results:The main pharmacokinetic parameters of Rifapentin were as follows:tmax were (4.700±2.364)and(4.700±1.750)h,t1/2were (16.215±2.356)and(16.825±4.595)h,Cmax were(11.774±5.134)and(10.771±4.868)mg·h·L-1;AUC0-twere(346.539±160.580)and(322.286±147.345)mg·h·L-1;AUC0-∞were(363.137±167.807)and(339.309±154.212)mg·h·L-1.The relative bioavailability of drug was(110.5±25.6)%.Conclusion:The two Rifapentin formulations are bioequivalent.

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Available abstract

Objective:To study the pharmacokinetics and bioequivalence of Rifapentin capsules in healthy volunteers.Methods:A single oral dose(0.6g tested and reference formulation)was given to 20 healthy volunteers according to an open randomized crossover design.Rifapentin concentration of plasma was determined by HPLC-UV.The pharmacokinetics parameters were calculated and the bioavailability and bioequivalence of two formulation were evaluated by DAS2.0 program.Results:The main pharmacokinetic parameters of Rifapentin were as follows:tmax were (4.700±2.364)and(4.700±1.750)h,t1/2were (16.215±2.356)and(16.825±4.595)h,Cmax were(11.774±5.134)and(10.771±4.868)mg·h·L-1;AUC0-twere(346.539±160.580)and(322.286±147.345)mg·h·L-1;AUC0-∞were(363.137±167.807)and(339.309±154.212)mg·h·L-1.The relative bioavailability of drug was(110.5±25.6)%.Conclusion:The two Rifapentin formulations are bioequivalent.

Key concepts: Bioequivalence, Pharmacokinetics, Bioavailability, Cmax, Crossover study, Medicine, Pharmacology, Alternative medicine

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