Evaluation of the bioequivalence of domestic and imported Potassium Sodium Hydrogen Citrate Granules with accumulative urinary excretion of calcium as index in healthy volunteers
ZHANG Hua
LIU Sha
LI Rong
WANG Ben-jie
GUO Rui-chen
Abstract：Objective To evaluate the bioequivalence of imported and domestic Potassium Sodium Hydrogen Citrate Granules with accumulative urinary excretion of calcium as index in Chinese healthy volunteers. Methods Thirty - six healthy male volunteers were randomLy administered with a oral single dose of 5. 0 g domestic(test)and imported(refer-ence)Potassium Sodium Hydrogen Citrate Granules in a crossover study with a washout period of 7 days. Urine was collect-ed before or after oral doses at the scheduled time(0 ~ 2,2 ~ 4,4 ~ 6,6 ~ 8,8 ~ 10,10 ~ 12,12 ~ 24 h). Urine volumes were recorded,urinary calcium concentration was determined by atomic absorption spectrophotometric and twenty - four hours of accumulative urinary excretion of calcium were calculated. Results Twenty - four hours of accumulative urinary excretion of calcium were(128. 47 ± 76. 45)mg and(163. 53 ± 81. 28)mg before and after taking test preparation;(128. 34 ± 59. 55)mg and(179. 65 ± 103. 96)mg before and after taking reference preparation,respectively. Increase in 24 h urinary excretion of calcium after taking test and reference preparation were(35. 06 ± 61. 26)mg and(51. 31 ± 73. 18)mg,respec-tively. There was no significant difference(P ﹥ 0. 05)in increase of 24 h accumulative urinary excretion of calcium between the two preparations. Conclusion The domestic and imported Potassium Sodium Hydrogen Citrate Granules were bioequiv-alent.
Keywords：Potassium Sodium Hydrogen Citrate GranulesReference preparationTest preparationCalciumBioequiv-alenceAtomic absorption spectrophotometry
Publication Date：2014-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 501-504 )