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目的:泊沙康唑是一种有效治疗和预防真菌感染的三唑类广谱抗真菌药物。市售的口服混悬液需与食物同服以使药物达到最大吸收。现已研发出一种生物利用度高且不需同时进食的新型固体口服片剂。本研究旨在评价健康受试者中该新制剂单剂和多剂剂量递增给药后的药动学特性、安全性以及耐受性。方法:该试验是单中心、随机、安慰剂对照、单次和多次给药剂量递增的I期临床试验。筛选18~65岁的健康受试者,共24名,分为2组,每组12名(9名服用试验药物,3名服用安慰剂)。第1组受试者接受200mg每天1次和每天2次
Objective: Posaconazole is a triazole broad spectrum antifungal agent that is effective in the treatment and prevention of fungal infections. Commercially available oral suspensions need to be taken with food to maximize drug absorption. A new solid oral tablet has been developed that is highly bioavailable and does not require simultaneous ingestion. The aim of this study was to evaluate the pharmacokinetic properties, safety and tolerability of single dose and multiple dose escalation of this new formulation in healthy subjects. METHODS: This trial is a single-center, randomized, placebo-controlled, phase I clinical trial of single and multiple dose escalation. A total of 24 healthy subjects aged 18-65 years were screened and divided into two groups of 12 (9 taking the test drug and 3 taking the placebo). Group 1 subjects received 200 mg once daily and 2 daily