药物研究
BU Yuehua;HONG Bo;ZHAO Min;ZHAO Chunjie
2009, 28(7): 846-848.
ABSTRACT Objective To evaluate the bioavailability and pharmacokinetics of two preparations of calcium folinate in healthy volunteers. Methods The randomized, crossedover study was conducted in 18 healthy volunteers. After a single dose of administration (containing 90 mg calcium folinate dispersed tablets), the plasma levels of medicines were determined by HPLC. The AUC0~12 of both forms were compared by variance analysis and twoway onesided t test. Conclusion The main pharmacokinetics parameters of test and reference preparation were as followed: tmax were (1.5±0.0) h and( 1.5±0.0) h, Cmax were (2 295.51±368.93) ng•mL1 and (2 139.53±189.67) ng•mL1, t1/2 were (2.19±0.16) h and (2.23±0.17) h, AUC012 were (6 202.09±229.90) ng•mL1•h and (6 185.32±191.47 ) ng•mL1•h, and AUC0∞ were (6 478.43±250.69 ) ng•mL1•h and (6 478.63±248.10 ) ng•mL1•h, respectively. Conclusion The Conclusion showed that the two formulations were bioequivalent. The relative bioavailability of calcium folinate dispersed tablets was (100.13±5.39)%.