Ceftazidime (SN401) の臨床第一相試験

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タイトル別名
  • PHASE-ONE CLINICAL STUDY ON CEFTAZIDIME
  • Ceftazidime SN401 ノ リンショウ ダイイチ シケン

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Ceftazidime (CAZ, SN401), a new parenteral cephalosporin antibiotic, was administered to 14 healthy male volunteers to study its tolerance and pharmacokinetics, by intramuscular injection (0.5g), 1-hour intravenous drip infusion (1g and 2g, in a cross over method), 2-hours intravenous drip infusion (2g), intravenous bolus injection (0.5g and 1g, in a cross over method) and multiple intravenous bolus injection (1g, at 12 hour intervals, 9 times).<BR>1. In the examinations on tolerance such as subjective and objective symptoms, physical examinations, haematology, serum biochemistry, urinalysis, etc., no abnormalities attributable to CAZ were noted.<BR>2. CAZ achieved high plasma levels after intramusclar and intravenous injections, corresponding to the increase of the administered dose. The plasma half life of CAZ was 1.6-2.1 hours, which was comparatively long, and even at 8 hours after administration, 0.9-5.7μg/ml of CAZ was detected in plasma.<BR>3. CAZ was not inactivated in the body and about 90% of the dose was excreted within 12 hours after administration regardless of dose levels or administration routes.<BR>4. In multiple dose of CAZ (1g of i. v. bolus injection, 9 times, 12 hourly), there was no variation in the plasma level and urinary excretion level, nor tendency to accumulation.<BR>From the above results, CAZ was considered to be a safe drug with favorable pharmacokinetics, and from its high antibacterial activity, CAZ was expected to be a clinically effective drug in various infections.

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