NCT00668538已完成不适用
Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
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
- 主要终点
- CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively
研究概览
简要总结
The purpose of this study, is to study the uptake of the pharmaceutical antifungal miconazole when used as a vaginal suppository in young women. The investigators want to know if the uptake is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-45 years
- •Signed consent
- •Written authority to the GCP-unit
排除标准
- •Pregnancy
- •Breast-feeding
- •Hypersensitivity to miconazole
- •Hypersensitivity to sodium ethyl parahydroxybenzoic acid(E219)
- •Hypersensitivity to sodium propyl parahydroxybenzoic acid (E217)
- •Using contraceptives with hormones
- •Daily consumption of alcohol
- •Daily use of medicine
- •Participated in a clinical trial within the last 3 months
结局指标
主要结局
CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively
时间窗: urine and blood collected day 4 and 8
次要结局
- Detection of miconazole or metabolites in blood and urine(Blood and urine collected day 8)
研究者
研究点 (2)
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