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Mechanismneuraminidase inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date13 Jan 2010 |
帕拉米韦吸入溶液在中国健康受试者中耐受性及药代动力学临床试验研究
[Translation] Clinical trial study on the tolerability and pharmacokinetics of peramivir inhalation solution in Chinese healthy subjects
(1)评价该吸入制剂在健康受试者中单次给药的耐受性和药代动力学特征;
(2)以药代动力学参数作为主要终点评价指标,比较该吸入制剂与注射制剂在健康受试者体内的药代动力学行为,计算该吸入制剂的绝对生物利用度;
(3)比较该吸入制剂与注射制剂在健康受试者鼻咽部及肺泡中的暴露量;
评价该吸入制剂在健康受试者中多次给药的耐受性及药代动力学特征。
[Translation] (1) Evaluate the tolerability and pharmacokinetic characteristics of the inhalation preparation after a single dose in healthy subjects;
(2) Compare the pharmacokinetic behavior of the inhalation preparation and the injection preparation in healthy subjects using pharmacokinetic parameters as the primary endpoint evaluation indicators, and calculate the absolute bioavailability of the inhalation preparation;
(3) Compare the exposure of the inhalation preparation and the injection preparation in the nasopharynx and alveoli of healthy subjects;
Evaluate the tolerability and pharmacokinetic characteristics of the inhalation preparation after multiple doses in healthy subjects.
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