NCT00695071已完成1 期
Assessment of the Steady State Pharmacokinetics of Itraconazole and Hydroxy-Itraconazole in Healthy Subjects After Administration of a New Itraconazole 200 mg Film Coated Tablet Once Daily for Fourteen Days in Fed Condition
Stiefel, a GSK Company1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Steady State Plasma levels of Itraconazole
研究概览
简要总结
The objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.0 and 28.0 kg/m2
- •Good physical and mental health status, determined on the basis of the medical history and a general clinical examination.
- •Vital signs (blood pressure and heart rate) in supine position within the normal range
- •Electrocardiogram (12 lead) considered as normal
- •Non-smoker.
- •Able to swallow pills
- •If subject is a woman of childbearing potential (WOCBP), must agree to use adequate birth control as defined by the protocol
排除标准
- •Any disease or physical condition which, in the opinion of the investigator, could impact the pharmacokinetics of the drug
- •History or presence of drug abuse or consumption of alcohol
- •History of sensitivity or allergy to azoles or related drugs
- •Any requirement to be on other drug treatment (except acetaminophen and for WOCBP, hormonal contraceptives)
- •Unsuitable veins for repeated venipuncture.
- •Clinically significant abnormal ECG
- •Nursing mothers and pregnant women, or women of childbearing potential not using adequate contraceptives.
研究组 & 干预措施
A
Active Comparator
干预措施: Itraconazole (Drug)
结局指标
主要结局
Steady State Plasma levels of Itraconazole
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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