Bioequivalence of candesartan cilexeticcapsule in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2017.06.009
- VernacularTitle:坎地沙坦酯胶囊在中国健康人体的生物等效性研究
- Author:
Su-Mei XU
1
;
Ren GUO
;
Dan LI
;
Xiao-Min LI
;
Dai LI
Author Information
1. 中南大学湘雅医院国家药物临床试验机构
- Keywords:
candesartan cilexetil;
pharmacokinetic parameter;
bioequivalence;
liquid chromatography/tandem mass spectrometry
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(6):509-512
- CountryChina
- Language:Chinese
-
Abstract:
Objective Toinvestigate the bioequivalence of domestic can desartan cilexetil capsules and imported candesartan cilexetil tablets in Chinese healthy subjects.Methods This is open,random and two way crossover clinical trial involved 24 healthy male subjects.A single oral dose 8 mg of domestic candesartan cilexetil capsules (test preparation) and imported candesartan cilexetil tablets (control preparation) was administrated under the condition of fasting.The plasma concentrations of candesartan were determined by LC-MS/MS.The pharmacokinetics parameters were calculated and the bioequivalence of two formulations were evaluated by WinNonlin program.Results The main pharmacokinetic parameters of the test and control preparation were as follows:t1/2 (9.30±1.70),(9.80 ± 1.90) h;tmax(4.00 ±0.80),(4.20 ± 1.00) h;Cmax (76.98 ± 22.22),(87.35 ±34.61) μg· L-1;AUC0-48h (826.60 ± 204.10),(928.00 ± 269.30) μg · h · L-1;AUC0-∞ (857.10 ±201.30),(956.10 ± 270.60) μg · h · L-1.The relative bioavailability of the test preparation (candesartan cilexetil capsules) was (114.40 ±27.30) ％.And 90％ confidence limit of test preparation of the logarithmic transformed parameters AUC0-48h,AUC0-∞,Cmax were in 101.37％-121.80％,101.08％-120.15％,98.59％-119.54％ compared with reference preparation,respectively.No significant difference was found by nonparametric test of tmax.Conclusion The developed and validated method is rapid,sensitive,selective and reliable for the determination of candesartan in human plasma.The domestic candesartan cilexetil capsules are bioequivalence to the imported candesartan cilexetil tablets.
