Pharmacokinetics of Single Oral Dose Adefovir Dipivoxil Tablet in Healthy Volunteer
- VernacularTitle:单剂量口服阿德福韦酯片人体药动学研究
- Author:
Ping ZHENG
;
Zhiliang CHEN
;
Minyan HU
;
Qing ZHANG
- Publication Type:Journal Article
- Keywords:
Adefovir dipivoxil;
LC/MS/MS;
Pharmacokinetics
- From:
China Pharmacy
2005;0(14):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the pharmacokinetics of oral single dose adefovir dipivoxil(ADV) tablet in Chinese healthy volunteers.METHODS:The study was a randomized,open,three-way crossover study.Twelve healthy volunteers were randomly assigned to receive single oral dose of 5 mg(Group A),10mg(Group B) or 30 mg(Group C) ADV tablets in three weeks.The plasma concentrations of ADV were determined by LC/MS/MS method.The pharmacokinetic parameters were computed.RESULTS:The main pharmacokinetic parameters in Group A,B and C were as follows:Cmax were(11.4? 3.7),(25.4? 8.2) and(76.3? 23.0) ng? mL-1;tmax were(1.69? 1.41),(0.90? 0.56) and(0.94? 0.50) h;AUC0～ t were(102.7? 51.7),(235.0? 82.3) and(715.4? 267.6) ng? h.mL-1;AUC0～ ∞ were(168.7? 30.7),(266.2? 83.7) and(741.5? 273.9) ng? h? mL-1,respectively.CONCLUSION:ADV tablets had a rapid absorption in healthy volunteers and the Cmax and AUC of adefovir tablets were directly correlated to doses.It is safe for healthy volunteers to take ADV tablets at a dose of 5～30mg.
