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Study on bioequivalence of famciclovir capsules in human

Ke Li

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Abstract

OBJECTIVE To study the pharmacokinetics and the relative bioavailability of famciclovir capsule.METHODS 12 healthy male volunteers were enrolled.Plasma concentrations of penciclovir were determined by HPLC with fluorescence detection following administration of the oral prodrug,famciclovir.RESULTS The pharmacokinetic parameters of famciclovir capsule and tablet were as follow: t max (0.774±0.190) and (0.748±0.181) h; c max (4.207±1.079) and (4.303±1.271) mg·L -1 ; AUC 0~∞ (15.476±3.654) and (14.828±3.420) mg·h·L -1 ,and AUC 0~t (14.622±3.605) and (14.072±3.459) mg·h·L -1 ,respectively.The relative bioavailability of famciclovir capsule was (104.5±10.2)%.CONCLUSION The test capsule and reference tablet of famciclovir were bioequivalent.

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OBJECTIVE To study the pharmacokinetics and the relative bioavailability of famciclovir capsule.METHODS 12 healthy male volunteers were enrolled.Plasma concentrations of penciclovir were determined by HPLC with fluorescence detection following administration of the oral prodrug,famciclovir.RESULTS The pharmacokinetic parameters of famciclovir capsule and tablet were as follow: t max (0.774±0.190) and (0.748±0.181) h; c max (4.207±1.079) and (4.303±1.271) mg·L -1 ; AUC 0~∞ (15.476±3.654) and (14.828±3.420) mg·h·L -1 ,and AUC 0~t (14.622±3.605) and (14.072±3.459) mg·h·L -1 ,respectively.The relative bioavailability of famciclovir capsule was (104.5±10.2)%.CONCLUSION The test capsule and reference tablet of famciclovir were bioequivalent.

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Available abstract

OBJECTIVE To study the pharmacokinetics and the relative bioavailability of famciclovir capsule.METHODS 12 healthy male volunteers were enrolled.Plasma concentrations of penciclovir were determined by HPLC with fluorescence detection following administration of the oral prodrug,famciclovir.RESULTS The pharmacokinetic parameters of famciclovir capsule and tablet were as follow: t max (0.774±0.190) and (0.748±0.181) h; c max (4.207±1.079) and (4.303±1.271) mg·L -1 ; AUC 0~∞ (15.476±3.654) and (14.828±3.420) mg·h·L -1 ,and AUC 0~t (14.622±3.605) and (14.072±3.459) mg·h·L -1 ,respectively.The relative bioavailability of famciclovir capsule was (104.5±10.2)%.CONCLUSION The test capsule and reference tablet of famciclovir were bioequivalent.

Key concepts: Famciclovir, Penciclovir, Bioequivalence, Capsule, Pharmacokinetics, Bioavailability, Prodrug, Medicine

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