PHASE I STUDY OF CINOXACIN

概要

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Cinoxacin (CINX), a new synthetic organic antibacterial, was administered orally to nineteen healthy adult male volunteers to study the degree of safety and pharmacological properties. In single dose studies, 19 volunteers were randomly assigned to the doses of 200mg, 400mg and 800mg of CINX or 500mg of nalidixic acid (NA) with or without food, then they received different dose every weekend for 4 weeks. In multiple dose studies, 7 volunteers received 400mg of CINX every 12 hours for nine days.<BR>Tolerance of administered CINX was, in general, good and no side effect or adverse reaction was found except one case with transient mild obstipation in multiple dose studies.<BR>The peak values of the mean plasma concentration observed at 1.5 or 2 hours after administration of 200, 400 and 800mg of CINX without food were 4.3, 9.3 and 20.3μg/ml, respectively. The plasma concentration was proportional to the dose. The elimination half-life was about 1 hour. The recovery of CINX in 12 hour urine was about 65% of the dose, which was much higher than that of NA. Although food delayed the absorption, the 12 hour urinary recovery was not significantly changed.
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