PHARMACOKINETICS OF ORAL GANCICLOVIR IN PEDIATRIC PATIENTS

儿科患者口服更昔洛韦的药代动力学

• 批准号: 6115525
• 负责人: Ellen Wald
• 金额: $ 2.06万
• 依托单位: CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6115525
• 关键词: blood chemistry; child (0-11); clinical research; clinical trial phase I; cytomegalovirus; cytomegalovirus retinitis; drug screening /evaluation; eye disorder chemotherapy; ganciclovir; gastrointestinal drug absorption; human subject; oral administration; pediatric pharmacology; pharmacokinetics; serum

Ganciclovir is a synthetic guanine derivative which interferes with the replication of viruses, including cytomegalovirus (CMV). The drug is effective for both treatment and chronic suppressive therapy of CMV infections in a variety of patients. The Food and Drug Administration has recently approved an oral form of ganciclovir as an alternative to parenteral drug in immunocompromised patient with CMV retinitis for chronic suppressive therapy. There are several pediatric patient groups who may benefit from use of oral ganciclovir. The purpose of our study is to obtain pharmacokinetic data by determining the absorption profile and achievable serum concentrations in children.

更昔洛韦是一种合成鸟嘌呤衍生物，可干扰病毒（包括巨细胞病毒（CMV））的复制。 该药物对各种患者的CMV感染的治疗和慢性抑制治疗都有效。 美国食品和药物管理局最近批准了口服形式的更昔洛韦作为替代胃肠外药物的免疫功能低下的患者与CMV视网膜炎的慢性抑制治疗。 有几个儿科患者群体可能受益于口服更昔洛韦的使用。 本研究的目的是通过确定儿童的吸收特征和可达到的血清浓度来获得药代动力学数据。