A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of a Single Oral Dose of VIMOVO (250 mg Naproxen/20 mg Esomeprazole)in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Observed maximum concentration (Cmax)
研究概览
简要总结
This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult volunteers.
详细描述
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of a Single Oral Dose of VIMOVO (250 mg Naproxen/20 mg Esomeprazole)in Healthy Adult Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Healthy male and female subjects aged 18 to 55 years
- •Capable of understanding and complying with the Clinical Study Protocol
- •Body mass index (BMI) of 19 to 30 kg/m2 and weight of 50 to 100 kg
排除标准
- •Previous enrollment in the present study
- •Receipt of another investigational product within 4 weeks before this study or plans to participate in another study at the same time as this study
- •Female subjects with a positive urine pregnancy test
结局指标
主要结局
Observed maximum concentration (Cmax)
时间窗: Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
time of maximum concentration (tmax)
时间窗: Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
area under the concentration-time curve from zero to time of last quantifiable concentration (AUC(0-t))
时间窗: Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
area under the concentration-time curve from zero to infinity (AUC)
时间窗: Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
apparent terminal rate constant (λz), apparent terminal half-life (t1/2)
时间窗: Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
apparent systemic clearance after extravascular dosing (CL/F)
时间窗: Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
apparent volume of distribution following extravascular dosing (Vz/F) for naproxen and esomeprazole
时间窗: Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
次要结局
- Incidence and severity of Adverse events during the study as a measure of safety and tolerability(Collected from administration of VIMOVO (Visit 2 [Residential period] Day 1) until the end of the study, including follow-up)
- Abnormalties in Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) as a measure of safety and tolerability(Labs will be taken from screening to follow up visit)
- Abnormalities in Vital signs as a measure of safety and tolerability(From screening to follow up visit)