NCT07272889已完成1 期
A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Oral Doses of Bemnifosbuvir/Ruzasvir Fixed-dose Combination on the Single-Dose Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/ Levonorgestrel) in Healthy Adult Female Participants of Non-Childbearing Potential
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- PK of EE/LNG (Cmax)
研究概览
简要总结
Drug-drug interaction study between Ethinyl Estradioll/Levonorgestrel and Bemnifosbuvir/Ruzasvir
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy post-menopausal or hormonally sterile female
- •Minimum body weight of 50 kg and body mass index (BMI) of 18.0-30 kg/m
- •Willing to comply with the study requirements and to provide written informed consent.
排除标准
- •Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-
- •Abuse of alcohol or drugs.
- •Use of other investigational drugs within 28 days of dosing.
- •Concomitant use of prescription medications, or systemic over-the-counter medications.
- •Other clinically significant medical conditions or laboratory abnormalities.
研究组 & 干预措施
EE/LNG
Experimental
干预措施: Ethinyl Estradioll/Levonorgestrel (EE/LNG) (Drug)
BEM/RZR
Experimental
干预措施: Bemnifosbuvir/Ruzasvir (BEM/RZR) (Drug)
BEM/RZR + EE/LNG
Experimental
干预措施: Bemnifosbuvir/Ruzasvir (BEM/RZR) + Ethinyl Estradioll/Levonorgestrel (EE/LNG) (Drug)
结局指标
主要结局
PK of EE/LNG (Cmax)
时间窗: Day 1,15
PK of EE/LNG (AUC)
时间窗: Day 1,15
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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