NL-OMON46113已完成不适用
A Single Center, Non-Randomized, Open-Label, One-Sequence, Two-Period Within-Subject Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Multiple Doses of Balovaptan in Healthy Volunteers - Balovaptan-itraconazole DDI study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •-Healthy male and female subjects
- •-18 to 65 years, inclusive, at screening
- •-BMI: 18 to 30 kg/m2, inclusive, at screening
- •-Non-smoking
- •-Women of childbearing potential and men must use contraceptive methods
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
研究者
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