Pharmacokinetic study of cefotetan disodium for injection in Chinese healthy volunteers / 中国药学杂志

ABSTRACT

OBJECTIVE: To study the pharmacokinetics of cefotetan disodium for injection in Chinese healthy volunteers. METHODS: Thirty healthy volunteers were randomly divided into 3 groups with 5 males and 5 females in each group. The volunteers in each group were administered a single dose of cefotetan disodium of 0.5, 1.0, or 2.0 g, respectively. Those who got dose of 1.0 g were administered twice daily for 7 d. The concentrations of cefotetan disodium in plasma were determined by HPLC while the pharmacokinetic parameters were calculated by DAS software. RESULTS: The main pharmacokinetic parameters of cefotetan disodium after single-dose intravenous administration were as follows ρmax(68.03 ± 15.95), (110.77 ± 17.67), (225.34 ± 19.63) mg · L-1; AUC0-15(242.88 ± 56.60), (415.22 ± 54.24), (856.18 ± 82.72) mg · h · L-1; t1/2(3.67 ± 0.48), (3.69 ± 0.40), (3.53 ± 0.26) h, respectively. The main pharmacokinetic parameters of cefotetan disodium after multiple-dose administration were as follows ρmax(123.60 ± 15.74) mg · L-1; AUC0-15 (444.38 ± 62.78) mg · h · L-1; AUCSS(426.87 ± 59.36) mg · h · L-1; t1/2(3.29 ± 0.36) h; ρav(35.57 ± 4.95) mg · L-1, respectively. CONCLUSION: Cefotetan disodium for injection displays linear pharmacokinetics in the dose range of 0.5 to 2.0 g after single intravenous dosing. There is no significant accumulation after repeated dosing. There is no significant difference in the pharmacokinetic parameters between female and male subjects. Copyright 2012 by the Chinese Pharmaceutical Association.