Pharmacokinetics of multiple-dose of pazufloxacin mesilate injection in Chinese healthy volunteers
Qing Yong-pin
Abstract
Qing Yong-pin
Abstract
Objective: To study the pharmacokinetics of single-and multiple-dose of pazufloxacin mesilate injection in Chinese healthy volunteers.Methods: Twelve healthy volunteers were enrolled to receive single-and multiple-dose of pazufloxacin mesilate injection twice daily for 5 days in an open randomized study.The plasma concentrations of pazufloxacin were determined by reverse phase high-pressure liquid chromatograph(RP-HPLC) method.Results: Pharmacokinetic profile conformed to an open two-compartment model as analyzed with DAS software.The pharmacokinetic parameters of the first single dose and the last multiple-dose method were as follows: the mean values of Cmax were(10.86±2.04) and(11.72±1.82)mg·L-1,AUC0~∞ were(18.29±2.36) and(19.22±2.80)mg·h·L-1,and t1/2β were(1.64±0.27) and(1.82±0.34)h.Conclusion: Multiple-dose of pazufloxacin mesilate injection is well tolerated in the healthy volunteers.The pharmacokinetics of multiple-dose pazufloxacin mesilate injection in healthy Chinese volunteers conforms to tow-compartment model,and no drug is accumulated after the multiple-dose.
A significance statement is not available in the OpenAlex record.
A contribution statement is not available in the OpenAlex record.
Method details are not available in the OpenAlex metadata.
Findings are not separately available in the OpenAlex metadata.
Limitations are not available in the OpenAlex metadata.
Application details are not available in the OpenAlex metadata.
Objective: To study the pharmacokinetics of single-and multiple-dose of pazufloxacin mesilate injection in Chinese healthy volunteers.Methods: Twelve healthy volunteers were enrolled to receive single-and multiple-dose of pazufloxacin mesilate injection twice daily for 5 days in an open randomized study.The plasma concentrations of pazufloxacin were determined by reverse phase high-pressure liquid chromatograph(RP-HPLC) method.Results: Pharmacokinetic profile conformed to an open two-compartment model as analyzed with DAS software.The pharmacokinetic parameters of the first single dose and the last multiple-dose method were as follows: the mean values of Cmax were(10.86±2.04) and(11.72±1.82)mg·L-1,AUC0~∞ were(18.29±2.36) and(19.22±2.80)mg·h·L-1,and t1/2β were(1.64±0.27) and(1.82±0.34)h.Conclusion: Multiple-dose of pazufloxacin mesilate injection is well tolerated in the healthy volunteers.The pharmacokinetics of multiple-dose pazufloxacin mesilate injection in healthy Chinese volunteers conforms to tow-compartment model,and no drug is accumulated after the multiple-dose.
Key concepts: Pharmacokinetics, Cmax, Medicine, Pharmacology