Relative Bioavailability and Bioequivalence of Valaciclovir Hydrochloride Tablets in Healthy Volunteers
- VernacularTitle:盐酸伐昔洛韦片人体相对生物利用度和生物等效性研究
- Author:
Lidong DENG
;
Jungang DENG
;
Hang DENG
;
Xiang FU
- Publication Type:Journal Article
- Keywords:
Valaciclovir hydrochloride tablets;
Bioavailability;
Bioequivalence;
HPLC
- From:
China Pharmacy
2005;0(17):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the pharmacokinetics and relative bioavailability of two kinds of preparations of valaciclovir hydrochloride.METHODS:This was a randomized two-way cross-over study.A total of 18 healthy volunteers were randomly assigned to receive single oral dose of test valaciclovir tablets(trial group) or reference valaciclovir tablets(control group),with the plasma aciclovir concentrations determined by HPLC,the pharmacokinetics parameters calculated and the relative bioavailability evaluated using 3p97 program.RESULTS:The main pharmacokinetic parameters test and reference valaciclovir hydrochloride tablets were as follows:AUC0～ 24:(12.85? 4.32) vs.(12.19? 4.63) ?g? h? mL-1;AUC0～ ∞:(14.65? 5.75) vs.(13.27? 5.03) ?g? h? mL-1;Cmax:(3.55? 0.92) vs.(3.71? 0.97) ?g? mL-1;tmax:(1.44? 0.43) h vs.(1.33? 0.37) h;t1/2:(6.23? 2.81) h and(4.55? 1.84) h.The relative bioavailability of the test valaciclovir tablets were(111.01? 23.52) %.CONCLUSION:The reference valaciclovir tablets and the test valaciclovir tablets were bioequivalent.
