�й���������־ 2009, 34(11) 695- DOI:   1001-8689��2009��11-0695-04  ISSN: 0412-1961 CN: 21-1139/TG

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PubMed
Article by Sun, E. X.
Article by Zhao, L. M.
Article by Qiu, F.
Article by He, X. J.
Article by Shu, X.
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Pharmacokinetics of faropenem sodium after a single or multiple intravenous doses in Chinese healthy volunteers
Laboratory of Clinical Pharmacology, Shengjing Hospital of China Medical University, Shenyang 110004
Abstract:

Objective The pharmacokinetics of faropenem were studied in single and multiple dose regimens. Methods A single-dose, open-label, randomized, four-period crossover dose study was carried out in 12 healthy volunteers. The subjects received intravenous infusion of 100, 200, 400 or 600 mg faropenem. 8 subjects were given 200mg of faropenem q8h for 7 days. The concentrations of faropenem in serum and urine were determined by HPLC method. Results The main pharmacokinetic parameter of the four groups ��100,200,400 and 600 mg�� were as follows�� Cmax = ��8.42 ±1.96�� mg/L, ��16. 64 ±3.09�� rag/L,��24.73 ±3.58�� mg/L, ��44. 43 ±3.93�� mg/L,T1/2 = ��1.72 ±0.72�� h,��1.60±0.33��h,��1.56±0.21��h,��1.36±0.09��h,AUC0-t= ��13.90-±2.96�� mg·h/L, ��26.98 ±5.75�� mg·h/L, ��38.29±5.29�� mg·h/L, ��70.58 ± 10.33�� mg·h/L,respeetively. Almost 30% of the administered drug was excreted unchanged in urine up to 12h after dosing. The steady-state pharmacokinetie parameters including C T1/2, AUC0.8, DF and Cav were �� 15.83 ± 3.96�� mg/L, �� 1.11 ± 0.27 �� h , �� 21.93 ± 3.59 �� mg· h/L, �� 5.34 ± 1.30 �� and �� 2.74 ± 0.45 �� mg/L, respectively. Conclusion In single-dose study, Cmax and AUC demonstrated linear pharmacokinetics from 100 to 600 mg. The accumulated recovery rates obtained in urine indicate renal excretion is the main pathway for the elimination of faropenem. No significant differences between genders were observed. Moreover, all doses of faropenem were well tolerated. There was no accumulation when faropenem was given with multiple doses.

Keywords: FaroPenem   Subjects    Pharmacokinetics  
�ո����� 2009-05-07 �޻�����  ����淢������  
DOI: 1001-8689��2009��11-0695-04
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