A Clinical Study to Evaluate the Steady State Pharmacokinetics of Baraclude in Participants With Hepatitis B Virus Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
- •Participants with chronic hepatitis B (CHB) (excluding participants with a superinfection) who have been confirmed to have CHB.
- •Participants who are being treated with 0.5 mg daily Baraclude for a minimum of 10 consecutive days prior to the study enrollment.
- •Body mass index (BMI) of 18.5 to 30 kg/m2 (BMI = body weight [kg]/height [m]2)
排除标准
- •Current or recent (within 3 months of Baraclude administration) gastrointestinal disease that could impact upon the absorption of study drug.
- •Any gastrointestinal surgery that could impact upon the absorption of study drug.
- •Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).
- •Other protocol defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
Arm A
干预措施: Baraclude (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: Up to 24 hours
Cmax is defined as the peak plasma concentration
Trough Observed Plasma (Predose) Concentration (Ctrough)
时间窗: prior to administration of drug (predose)
Ctrough is defined as the trough in observed plasma (predose) concentrations
Time of Maximum Observed Plasma Concentration (Tmax)
时间窗: Up to 24 hours
Tmax is defined as the time of maximum observed plasma concentration, measured in hours
Observed Plasma Concentration at 24 Hours Postdose (C24)
时间窗: 24 hours post-dose
C24 is defined as the observed plasma concentration at 24 hours post-dose
Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)]
时间窗: Up to 24 hours
AUC(TAU) is defined as the area under the concentration-time curve in one dosing interval
Apparent Total Body Clearance (CLT/F)
时间窗: Up to 24 hours
CLT/F is defined as the apparent total body clearance
次要结局
未报告次要终点