A Phase I, Randomised, Open-label, 3 Way Cross-over Study in Healthy Volunteers to Demonstrate the Bioequivalence of the Naloxegol 25 mg Commercial and Phase III Formulations and to Assess the Effect of Food Administration on the Pharmacokinetics of the Commercial Formulation.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Description of the pharmacokinetic (PK) profile for naloxegol in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) for each treatment period.
研究概览
简要总结
The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.
详细描述
A Phase I, Randomised, Open-label, 3 way Cross-over Study in Healthy Volunteers to Demonstrate the Bioequivalence of the Naloxegol 25 mg Commercial and Phase III Formulations and to Assess the Effect of Food Administration on the Pharmacokinetics of the Commercial Formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Female non-pregnant, non-lactating.
- •Volunteers with suitable veins for cannulation or repeated venipuncture.
- •Male healthy volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the investigational product.
- •The female partner should use contraception during this period.
排除标准
- •History of any clinically significant disease or disorder.
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product.
- •Volunteers who have smoked or used nicotine products within the previous 3 months from the date of screening.
- •Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the Investigator .
研究组 & 干预措施
A
Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fasted conditions
干预措施: Naloxegol (Drug)
B
Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fed conditions
干预措施: Naloxegol (Drug)
C
Naloxegol film-coated IR tablet 25 mg Phase III formulation under fasted conditions
干预措施: Naloxegol (Drug)
结局指标
主要结局
Description of the pharmacokinetic (PK) profile for naloxegol in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) for each treatment period.
时间窗: Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
次要结局
- Description of the safety profile in terms of adverse events, clinical laboratory assessments , vital signs (blood pressure and pulse rate), physical examinations, electrocardiograms, and Columbia-Suicide Severity Rating scale (CSSRS)(From baseline day 1 through to Follow-up (Maximum 40 days))
- Description of the pharmacokinetic(PK) profile for naloxegol in terms of time to Cmax (tmax), terminal half-life (t1/2λz), terminal rate constant (λz). For each treatment period(Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours)
- Description of the pharmacokinetic (PK) profile for naloxegol in terms of area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)].For each treatment period(Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours)
- Description of the pharmacokinetic (PK) profile for naloxegol in terms of area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)], apparent oral clearance from plasma (CL/F).For each treatment period(Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours)
- Description of the pharmacokinetic (PK) profile for naloxegol in terms of apparent volume of distribution during the terminal phase (Vz/F)For each treatment period(Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours)