Absolute oral bioavailability and disposition of deferasirox in healthy human subjects.

Sechaud R; Robeva A; Belleli R; Balez S

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Absolute oral bioavailability and disposition of deferasirox in healthy human subjects.

机译：在健康人类受试者中绝对口服生物利用度和地拉罗司的处置。

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Deferasirox is a novel iron chelator formulated as tablets for dispersion (suspension) for once-a-day oral administration. The current study evaluated the absolute bioavailability of a single 375-mg oral dose of deferasirox administered in the form of tablets compared with a 130-mg intravenous infusion of deferasirox. Since this was a first-in-man study using the deferasirox intravenous (IV) formulation, the safety and tolerability of the IV formulation was evaluated in a pilot phase with a lower dose (65 mg) in 3 subjects prior to the main phase. The main study phase consisted of 17 healthy male volunteers. Plasma concentrations of deferasirox were measured following each treatment, and pharmacokinetic parameters including absolute oral bioavailability were determined. Absolute oral bioavailability of the deferasirox tablets was 70% (90% confidence interval, 62%-80%). Deferasirox was characterized as having a low plasma clearance of 3.53 (+/- 0.87) L/h. A small volume of distribution of deferasirox atsteady state (V(ss)) of 14.37 (+/-2.69 L) was determined, indicating a low tissue distribution.

机译：Deferasirox是一种新型铁螯合剂，配制成片剂，用于每天口服一次的分散（混悬剂）。当前的研究评估了单剂量375 mg口服地拉罗司片剂的绝对生物利用度与130 mg静脉注射地拉罗司的绝对生物利用度。由于这是使用地拉罗司静脉（IV）制剂进行的首次人体研究，因此在试验期之前对3个受试者在主要阶段之前以较低剂量（65 mg）评估了IV制剂的安全性和耐受性。主要研究阶段包括17名健康男性志愿者。每次治疗后测定地拉罗司的血浆浓度，并确定包括绝对口服生物利用度在内的药代动力学参数。地拉罗司片的绝对口服生物利用度为70％（90％置信区间，62％-80％）。地拉罗司的特征是血浆清除率低，为3.53（+/- 0.87）L / h。确定了14.37（+/- 2.69 L）的小剂量Deferasirox稳态分布（V（ss）），表明组织分布低。

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《The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology》 |2008年第8期|共7页
作者
Sechaud R; Robeva A; Belleli R; Balez S;
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正文语种 eng
中图分类药理学;
关键词
Oral; Biological Availability; Absolute; Roman Numeral IV; 生物利用度;

机译：Oral;Biological Availability;Absolute;Roman Numeral IV;生物利用度;

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机译：在健康人类受试者中绝对口服生物利用度和地拉罗司的处置。
2. Absolute bioavailability of imidafenacin after oral administration to healthy subjects. [J] . Ohno T, Nakade S, Nakayama K, British Journal of Clinical Pharmacology . 2008,第2期

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6. Absolute Bioavailability and Disposition of (−) and (+) 2′-Deoxy- 3′-Oxa-4′-Thiocytidine (dOTC) following Single Intravenous and Oral Doses of Racemic dOTC in Humans [O] . Patrick F. Smith, Alan Forrest, Charles H. Ballow, 2000

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Absolute oral bioavailability and disposition of deferasirox in healthy human subjects.

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