ACTRN12618000798268已完成1 期
An Open-Label, Non-Randomized, Fixed-Sequence Study in Healthy Volunteers to Evaluate the Effect of HM30181A on the Pharmacokinetics of Digoxin
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Athenex Inc
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Males and females aged at least 18 years and up to 55 years on day of consent; Creatinine clearance >=80 mL/min; non-smoker; in good health; Body mass index (BMI) greater than or equal to 18.0 and <30.0 kg/m2 at Screening; willing to adhere to the alcohol and caffeine restrictions. Females must be postmenopausal or surgically sterile or must be using effective
- •contraception for at least 4 weeks prior to dosing and agree to continue use of
- •contraception for 30 days after their last dose.
排除标准
- •A history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; an elevated prothrombin time (PT) or aPTT or platelet count below the lower limit of normal at Screening or Baseline; History of gastrointestinal bleeding, intracerebral bleeding or frequent nose-bleeds or active bleeding; prolonged QTc interval (QTc >450 ms), or PR interval >180ms or QRS interval >110ms on ECG at Screening; Heart rate <45bpm; Wolff-Parkinson-White syndrome; serum potassium or calcium concentration below the lower limit of normal; history of drug or alcohol abuse or dependence; taking any prescription drug or herbal medicine or supplement within 2 weeks or 5 half-lives prior to dosing, whichever is longer, or vitamin supplement within 1 week prior to dosing; clinically significant drug allergy.
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