Pharmacokinetics and relative bioavailability of Gliclazide capsules in healthy volunteers
- VernacularTitle:格列齐特胶囊人体药代动力学及相对生物利用度研究
- Author:
Cen LI
- Publication Type:Journal Article
- Keywords:
Gliclazide;
Bioavailability;
Pharmacokinetics;
HPLC
- From:
Journal of Chongqing Medical University
1986;0(03):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective:The relative bioavailability and pharmacokinetics of Chongqing Lisi(LSGL) or Shanxi Fenghe Gliclazide capsules(FHGL) were studied in 20 healthy male volunteers. Methods:A single dose of 50mg of LSGL or FHGL was administered by randvmized crossover way in 20 volunteers and the plasma concentrations of Gliclazide(GL) were determined by HPLC.The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioequivalency was evaluated.Results:The concentration-time curves of two proparations fitted to one-compartment model.The peak plasma levels (C max ) of LSGL and FHGL were 4.50?0.83 and 4.54?l.04?g/ml,respectively;the peak time (T max ) was 4.05+0.89 and 4.05?0.76h,respectively;and AUC (0~T) were 80.30?26.87,82.59?26.20?g?h?ml -1 ,respectively.The relative bioavailability of LSGL was 97.23?12.58%.Conclusion:The result of two one-side tests suggest that the LSGL is bioequivalent to the FHGL.