A Study to Assess the Absorption of Apixaban (BMS-562247) Sprinkle Capsules Compared With Tablets in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time
研究概览
简要总结
The purpose of this study is to evaluate the absorption of apixaban (BMS-562247) into the bloodstream of healthy volunteers, when administered as sprinkle capsules compared to tablets. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single oral dose of apixaban twice during the course of the study.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form.
- •Healthy male and female participants determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs (electrocardiograms), vital signs and clinical laboratory determinations.
- •Women of childbearing potential (WOCBP) must have negative serum pregnancy tests (performed at screening and Day 1), must not be breastfeeding, and must agree to follow instructions for method(s) of contraception for duration of treatment with study drug apixaban, and for a total of 33 days after last dose of apixaban.
- •Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with study drug apixaban, and for a total of 93 days after the last dose of apixaban; and must be willing to refrain from sperm donation during this time.
- •Body mass index (BMI) of 18.0 to 30.0 kg/m², inclusive. Body mass index = weight (kg)/[height(m)]².
排除标准
- •History of chronic headaches (occurring 15 days or more a month) over the previous 3 months.
- •History of gastroesophageal reflux disease, dyspepsia, protracted nausea, or chronic diarrhea.
- •History or evidence of abnormal bleeding or coagulation disorders, hypermenorrhea, intracranial hemorrhage, or abnormal bleeding or coagulation disorders.
- •Inability to comply with restrictions and prohibited treatments (e.g. women currently taking hormonal contraception).
- •Use of tobacco- or nicotine-containing products (e.g. cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, nicotine gum) within 6 months prior to study drug administration.
- •Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).
- •Other protocol defined inclusion/exclusion criteria could apply.
结局指标
主要结局
AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time
时间窗: Day 1 to Day 8
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time
Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)
时间窗: Day 1 to Day 8
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration
AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration
时间窗: Day 1 to Day 8
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time
次要结局
- T-Half - Terminal Plasma Half Life.(Day 1 to Day 8)
- Physical Measurement - Height(Pre-treatment Screening)
- Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation(Day 1 to Day 38)
- Tmax - Time of Maximum Observed Plasma Concentration(Day 1 to Day 8)
- Frel - Relative Bioavailability(Day 1 to Day 8)
- Physical Measurement - Weight(Pre-treatment screening to Day 8)
- Physical Measurement - Body Mass Index (BMI)(Pre-treatment Screening to Day 8)
- Number of Participants With a Given Clinical Laboratory Abnormality(Day 1 to Day 8)
- Number of Participants With Out-of Range Vital Signs: Blood Pressure(Day 1 to Day 8)
- Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)(Day 1 to Day 8)
- Number of Participants With Out-of Range Vital Signs: Respiration Rate(Day 1 to Day 8)
- Number of Participants With Out-of Range Vital Signs: Temperature(Day 1 to Day 8)
- Number of Participants With Out-of Range ECG Evaluations(Day 1 to Day 8)