Pharmacokinetic and Bioequivalence Studies of Calcitriol Soft Capsules in Healthy Chinese Volunteers
A highly sensitive LC-MS/MS method was established for detecting calcitriol content in human plasma,with a lower limit of quantification of 20 pg/mL,which could meet the clinical detection needs.A randomized,open,three cycles,triple crossover design was used to investigate and compare the pharmacokinetic characteristics and bioequivalence between the tested preparation and the commercially available reference preparation of calcitriol in 36 healthy Chinese volunteers who were given a single oral administration of calcitriol soft capsules(at a dose of 4.0 pg)on an empty stomach.The results showed that the main pharmacokinetic parameters of the tested preparation and the reference preparation were as follows:tmax were(3.46±1.33)and(2.92±1.47)h,t1/2 were(8.14±3.22)and(7.70±2.32)h,cmax were(160.68±52.41)and(169.00±50.26)pg/mL,respectively.The variance in plasma concentrations of the tested and the reference preparations showed the same trend.The geometric mean ratios of the main pharmacokinetic parameters were within the 90％confidence interval of 80.00％-125.00％,indicating that the test and reference formulations were bioequivalent.
NETL
NSTL
万方数据
