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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2012  >  30(5): 372-375

SUI Miao, WANG Xiao-bo, XI Rong-gang, SUN Jia-dan. Pharmacokinetics and relative bioavailability of Sparfloxacin in healthy volunteer[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(5): 372-375. doi: 10.3969/j.issn.1006-0111.2012.05.015
Citation: SUI Miao, WANG Xiao-bo, XI Rong-gang, SUN Jia-dan. Pharmacokinetics and relative bioavailability of Sparfloxacin in healthy volunteer[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(5): 372-375. doi: 10.3969/j.issn.1006-0111.2012.05.015
shu

Pharmacokinetics and relative bioavailability of Sparfloxacin in healthy volunteer

doi: 10.3969/j.issn.1006-0111.2012.05.015
  • 1.

    The 210th Hospital of P.L.A., State Institution for Drug Clinical Trials, Dalian 116021, China

  • 2.

    Dalian Medical University, Dalian 116015, China

  • Received Date: 2012-02-27
  • Rev Recd Date: 2012-05-02
  • Objective To determine Sparfloxacin concentrations in human plasma and study the pharmacokinetics and relative bioavailability of Sparfloxacin for Suspension. Methods A single dose reference and test was given to 20 healthy volunteers in a randomized 2-way cross-over study. The plasma Sparfloxacin concentrations were determined by HPLC. The pharmacokinetics as well as relative bioavailability was measured. Results The main pharmacokinetic parameters of two formulations, Sparfloxacin in test and reference drug were as follows:tmax were (4.68±0.44)and(4.55±0.51)h;Cmax were(1 560.4±243.9)and(1 584.1±273.9)ng/ml;t1/2 were(20.92±4.85)and (19.81±3.75)h;AUC0-t were (43 325±12 174)and(44 139±11 815)ng·h/ml;AUC0-∞ were(45 452±12 884)and(45 999±12 629)ng·h/ml respectively. Using DASS program, the results of variance and two one-sided t-test statistical analyses for Ln Cmax. Two formulations were bioequivalent. Conclusion The reference and test Sparfloxacin were bioequivalent.
  • [1] 中国药典2005版.二部[S]. 2005,附录173.
    [2] 中国药典2005版.二部[S]. 2005,161.
    [3] 钟大放. 以加权最小二乘法建立生物分析标准曲线的若干问题[J]. 药物分析杂志,2006,16(5):343.
    [4] 梁竹,潘菡清,袁成,等. 高效液相色谱法测定血清和尿中司帕沙星的药物浓度[J]. 解放军药学学报, 2005,15(3):40.
    [5] 张毕奎,杨宇,李焕德,等. 国产司帕沙星片在老年人体内的药动学研究[J]. 临床药学,2008,37(2):120.
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Pharmacokinetics and relative bioavailability of Sparfloxacin in healthy volunteer

doi: 10.3969/j.issn.1006-0111.2012.05.015
  • 1. The 210th Hospital of P.L.A., State Institution for Drug Clinical Trials, Dalian 116021, China
  • 2. Dalian Medical University, Dalian 116015, China
  • Received Date: 2012-02-27
  • Rev Recd Date: 2012-05-02

Abstract: Objective To determine Sparfloxacin concentrations in human plasma and study the pharmacokinetics and relative bioavailability of Sparfloxacin for Suspension. Methods A single dose reference and test was given to 20 healthy volunteers in a randomized 2-way cross-over study. The plasma Sparfloxacin concentrations were determined by HPLC. The pharmacokinetics as well as relative bioavailability was measured. Results The main pharmacokinetic parameters of two formulations, Sparfloxacin in test and reference drug were as follows:tmax were (4.68±0.44)and(4.55±0.51)h;Cmax were(1 560.4±243.9)and(1 584.1±273.9)ng/ml;t1/2 were(20.92±4.85)and (19.81±3.75)h;AUC0-t were (43 325±12 174)and(44 139±11 815)ng·h/ml;AUC0-∞ were(45 452±12 884)and(45 999±12 629)ng·h/ml respectively. Using DASS program, the results of variance and two one-sided t-test statistical analyses for Ln Cmax. Two formulations were bioequivalent. Conclusion The reference and test Sparfloxacin were bioequivalent.

SUI Miao, WANG Xiao-bo, XI Rong-gang, SUN Jia-dan. Pharmacokinetics and relative bioavailability of Sparfloxacin in healthy volunteer[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(5): 372-375. doi: 10.3969/j.issn.1006-0111.2012.05.015
Citation: SUI Miao, WANG Xiao-bo, XI Rong-gang, SUN Jia-dan. Pharmacokinetics and relative bioavailability of Sparfloxacin in healthy volunteer[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(5): 372-375. doi: 10.3969/j.issn.1006-0111.2012.05.015
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