Sitafloxacin第I相臨床試験

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  • Pharmacokinetics of sitafloxacin (DU-6859a) in healthy volunteers
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We studied the pharmacokinetics of sitafloxacin (STFX) in healthy male volunteers given single oral doses 25 mg, 50 mg, 100 mg (fasting and non fasting state), or 200 mg. Non compartmentalanalysis was used to calculate pharmacokinetic parameters of STFX. Cmax of 0.29, 0.51, 1.00, 0.88, and 1.86 of serum appeared within 1 to 2 h after administration. After Cmax was reached, serum drug levels decreased with elimination half-lives of 5 to 6 h. Cmax and AUC0-inf increased in a dose proportional manner. We found a goodlinear correlation between administered doses and resulting Cmax and AUC0-inf. Food intake did not significantly influence STFX pharmacokinetics.

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