Abstract��
OBJECTIVE To study the pharmacokinetics and bioequivalence of cyclosporin A capsules in Chinese healthy volunteers.METHODS Eighteen Chinese healthy male volunteers were involved in the study.Each subject received a single dose of 200 mg cyclosporin A test or reference preparation.Blood sampling was conducted consequently within 48 h.The whole blood concentration were determined by HPLC.The pharmacokinetic parameters were caculated and bioequivalence of three preparations were evaluated by DAS software.RESULTS The main pharmacokinetic parameters were as follows:��max were(947.161��174.985),(758.869��193.539) and(938.711��202.379) ��g��L-1;tmax were(1.694��0.645),(2.472��0.581) and(1.861��0.564) h;t1/2 were(25.014��17.692),(28.032��14.602) and(28.056��22.927) h;AUC0-48h were(6 563.683��1 342.601),(6 152.483��1 066.901) and(6 594.165��927.042) ��g��h��L-1;AUC0-�� were(7 113.479 ��1 655.657),(6 771.877��1 240.034) and(7 253.950��1 228.181) ��g��h��L-1 for Sandimmun,Implanta and Tianke capsules,respectively.CONCLUSION The result of statistical analysis shows that the three preparations are bioequivalent.
GUO Tao,
QIN Hai-xu,
XIA Dong-ya etc
.Pharmacokinetics and Bioequivalence of Three Preparations of Cyclosporine A in Chinese Healthy Volunteers [J] Chinese Pharmaceutical Journal, 2008,V43(07): 535-537
2008, Vol. 43 
