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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date10 Aug 1972 |
注射用D(-)磺苄西林钠健康受试者单次和多次给药耐受性、药动学及与注射用磺苄西林钠比较药动学研究
[Translation] Single- and multiple-dose tolerance, pharmacokinetics and pharmacokinetics of D(-) Sulfenbenicillin Sodium for Injection in healthy subjects
1) 评价注射用D(-)磺苄西林钠在健康受试者中单次和多次给药的安全性、耐受性和药代动力学特征,为II期临床试验给药方案提供安全剂量范围,为制定合理的临床方案提供依据。 2)比较注射用D(-)磺苄西林钠和含有相同D(-)磺苄西林钠剂量的注射用磺苄西林钠在健康受试者中单次给药的药代动力学特征和尿药排泄情况。
[Translation] 1) To evaluate the safety, tolerability and pharmacokinetic characteristics of single and multiple doses of D(-) Sulbenicillin sodium for injection in healthy subjects, and to provide a safe dosing regimen for phase II clinical trials The dose range provides a basis for formulating a reasonable clinical program. 2) To compare the pharmacokinetic characteristics and urinary tract of a single dose of D(-) Sulbenicillin Sodium for Injection and Sulfombicillin Sodium for Injection containing the same dose of D(-) Sulbenicillin Sodium in healthy subjects Drug excretion.
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