NCT06921941已完成1 期
A Phase 1, Open-Label, Two-Part Study to Evaluate the Effect of a Single Oral Dose of Bemnifosbuvir/Ruzasvir Fixed Dose Combination on the Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- PK of Digoxin and Rosuvastatin (Cmax)
研究概览
简要总结
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir and Digoxin or Rosuvastatin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug.
- •Minimum body weight of 50 kg and body mass index (BMI) of 18-30 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
Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR
Experimental
干预措施: Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR (Drug)
Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR
Experimental
干预措施: Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR (Drug)
结局指标
主要结局
PK of Digoxin and Rosuvastatin (Cmax)
时间窗: Digoxin: Days 1,15, 29; Rosuvastatin: Days 1, 8, 15
PK of Digoxin and Rosuvastatin (AUC)
时间窗: Digoxin: Days 1,15, 29; Rosuvastatin: Days 1, 8, 15
次要结局
未报告次要终点
研究者
研究点 (1)
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