NCT00002251已完成不适用
A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
研究概览
简要总结
This study is designed to determine the influence of food on the absorption and relative bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed and fasting state at steady state plasma levels.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have the following:
- •Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV.
- •Documented confirmation of present or past CMV infection.
- •Must understand the nature of the study, agree to tests required in the protocol, and must understand and sign an informed Consent form approved by the appropriate Institutional Review Board and by Syntex.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Uncontrolled diarrhea or clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain.
- •Concurrent Medication:
- •Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT). Any investigational drug.
- •Patients with the following are excluded:
- •Any concomitant conditions listed in Exclusion Co-Existing Conditions.
- •Karnofsky score <
- •Hypersensitivity to acyclovir.
- •Displaying signs of dementia or decreased mentation which would interfere with the ability of the subject to follow protocol schedule.
- •Prior Medication:
- •Anti-cytomegalovirus therapy including ganciclovir therapy for treatment of CMV disease.
- •Excluded within 4 days of study entry:
- •Antimetabolites.
- •Interferons.
- •Other nucleoside analogs.
- •Zidovudine (AZT).
研究者
研究点 (2)
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