Pharmacokinetic and relative bioavailability of simvastatin tablet in healthy volunteers
Xiu Zhang · Chinese Journal of Hospital Pharmacy · 2004
OBJECTIVE To study the pharmacokinetic and relative bioavailability of simvastatin tablet in healthy volunteers. METHODS A high performance liquid chromatography(HPLC) was established for the determination of simvastatin in plasma after a single oral dose of 20 mg domestic simvastatin tablet and imported simvastatin tablet in a crossed design ,the detector was operated at UV 239 nm .RESULTS The pharmacokinetic parameters after a single oral dose of 20 mg domestic simrastain tablet and imported simvastatin tablet were as follows: C max were ( 12.0 ± 3.0) mg ·L -1 and ( 12.58 ± 3.61) mg ·L -1 ; t max were ( 2.0 ± 0.4) h and ( 1.89 ± 0.34) h ; t 1/2 were ( 2.18 ± 0.31) h and ( 2.22 ± 0.26) h ; K a were ( 1.3 ± 1.0 ) h -1 and ( 1.01 ± 1.31 ) h -1 ;AUC were ( 75.0 ± 18.2 ) and ( 79.1 ± 16.8 ).CONCLUSIONS The relative bioavailability of the domestic tablet was ( 97.2 ± 8.3)% .