NCT02456129已完成1 期
An Open-label Study to Evaluate the Effect of Repeated Oral Administration of 200 mg Itraconazole(ITZ) Given Once Daily Over 14 Days on the Single Oral Dose Pharmacokinetics of Vilaprisan (BAY1002670) as Well as Assessment of Absolute Bioavailability Using a Single Intravenous Microtracer Dose of [14C]Vilaprisan in Healthy Postmenopausal Women
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
- Bayer
- 入组人数
- 14
- 主要终点
- Area under the concentration time curve [AUC(0-11d)] after single oral dose of vilaprisan with and without ITZ.
研究概览
简要总结
This is a study in postmenopausal women to investigate the Drug-drug interaction (DDI) between itraconazole(ITZ) and orally administered vilaprisan; absolute bioavailability using intravenous microtracer dose of [14C]vilaprisan.
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI): 18 ≤ BMI ≤ 32 kg/m²
- •Postmenopausal state revealed by:
- •Medical history, if applicable (natural menopause at least 12 months prior to first study drug administration; or surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration), in addition: in women < 65 years old, follicle stimulating hormone (FSH) > 40 IU/L
排除标准
- •Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
- •Known or suspected liver diseases
- •Clinically relevant findings(e.g. blood pressure, electrocardiogram(ECG); physical and gynecological examination, laboratory examination)
研究组 & 干预措施
Vilaprisan + Itraconazole
Experimental
Vilaprisan (BAY1002670)
干预措施: Vilaprisan (BAY1002670) (Drug)
Vilaprisan + Itraconazole
Experimental
Vilaprisan (BAY1002670)
干预措施: [14C] Vilaprisan (Drug)
Vilaprisan + Itraconazole
Experimental
Vilaprisan (BAY1002670)
干预措施: Itraconazole(ITZ) (Other)
结局指标
主要结局
Area under the concentration time curve [AUC(0-11d)] after single oral dose of vilaprisan with and without ITZ.
时间窗: up to 14 days
Maximum plasma concentration (Cmax) after single oral dose of vilaprisan with and without ITZ.
时间窗: up to 14 days
次要结局
未报告次要终点
研究者
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