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Safety, Tolerability, and Pharmacokinetics of a Novel Oral Amphotericin B Formulation (iCo-019) following Single-Dose Administration to Healthy Human Subjects: an Alternative Approach to Parenteral Amphotericin B Administration.
Antimicrobial Agents and Chemotherapy ( IF 4.1 ) Pub Date : 2020-09-21 , DOI: 10.1128/aac.01450-20
Peter Hnik 1 , Ellen K Wasan 2 , Kishor M Wasan 3, 4
Affiliation  

This study evaluated the safety, tolerability, and pharmacokinetics of a novel oral amphotericin B (AmB) formulation (iCo-019) following single doses to healthy humans. The data from this study suggest that iCo-019 has a long circulation time and systemic exposure without the associated gastrointestinal, liver, and kidney toxicity associated with AmB. This novel oral AmB formulation can serve as a new treatment strategy to overcome the limitations of the use of parenterally administered AmB products.

中文翻译:

向健康人类受试者单次给药后,新型口服两性霉素B制剂(iCo-019)的安全性,耐受性和药代动力学:肠胃外两性霉素B给药的替代方法。

这项研究评估了单剂量对健康人类的新型口服两性霉素B(AmB)制剂(iCo-019)的安全性,耐受性和药代动力学。这项研究的数据表明,iCo-019具有较长的循环时间和全身性暴露,而没有与AmB相关的胃肠道,肝脏和肾脏毒性。这种新颖的口服AmB制剂可以作为一种新的治疗策略,以克服使用非肠道给药AmB产品的局限性。
更新日期:2020-09-21
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