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Safety Tolerability and Pharmacokinetics (PK) of Posaconazole (POS) Intravenous (IV) Solution and Oral Powder for Suspension in Children With Neutropenia

机译:泊沙康唑(POS)静脉(IV)溶液和口服粉剂对中性粒细胞减少症儿童的安全性耐受性和药代动力学(PK)

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摘要

BackgroundPOS, a triazole antifungal approved for prophylaxis and treatment of adults with invasive fungal infections, is available as an IV solution and 2 oral formulations: an oral suspension and a tablet with improved bioavailability. A novel powder for oral suspension (PFS) has been developed to offer the bioavailability of the tablet in a formulation optimized for weight-based dosing in children. The objective of this study is to evaluate the safety, tolerability, and PK of POS IV and POS PFS in pediatric patients (patients) aged 2 to 17 y with documented or expected neutropenia.
机译:背景技术POS是一种三唑类抗真菌药,已批准用于预防和治疗成人侵袭性真菌感染,它可以静脉注射液和2种口服制剂的形式提供:口服混悬液和生物利用度提高的片剂。已开发出新颖的口服混悬剂粉(PFS),以针对儿童基于体重的剂量优化的配方提供片剂的生物利用度。这项研究的目的是评估2至17岁有记录或预期中性粒细胞减少的儿科患者(患者)的POS IV和POS PFS的安全性,耐受性和PK。

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