NCT01225939已完成1 期
A Randomised, Open-label, Three-way Cross-over, Phase I Study in Healthy Subjects to Assess the Pharmacokinetics of AZD8329 After Single Doses of the Oral Solid Formulation and the Oral Solution
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Compare the pharmacokinetics (Cmax and AUC) of the oral solution and the oral solid formulation of AZD8329.
研究概览
简要总结
A study conducted over 3 periods to look at the drug in the body.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in CYP3A5
- •suitable veins for cannulation or repeated venepuncture
- •Subjects should have a body mass index (BMI) between 18 and 30 kg/m2
排除标准
- •Abnormal vital signs (blood pressure and pulse) after 10 minutes supine rest, as judged by the investigator
- •Prolonged QTcF >450 msec or shortened QTcF <350 msec or family history of long QT syndrome
- •Suspicion of known Gilbert's disease
- •History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
研究组 & 干预措施
3
Experimental
Single Oral dose AZD8329 tablet (Fed)
干预措施: AZD8329 (Drug)
1
Experimental
Single Oral dose AZD8329 tablet (fasting)
干预措施: AZD8329 (Drug)
2
Experimental
Single Oral dose AZD8329 solution (fasting)
干预措施: AZD8329 (Drug)
结局指标
主要结局
Compare the pharmacokinetics (Cmax and AUC) of the oral solution and the oral solid formulation of AZD8329.
时间窗: Information will be collected during 48h after each dose.
次要结局
- Explore the effect of food on the pharmacokinetics (Tmax, T1/2 and CL/F) of AZD8329 oral solid formulation.(Information will be collected during 48h after dose.)
- Investigate the safety and tolerability of AZD8329 administered as two different oral formulations.(Safety variables: Adverse events, Vital Signs, Clinical chemistry, Electrocardiogram (p ECG))(Adverse event will be collected from first dose to last visit . Clinical chemistry, Vital Signs and pECG's will be collected at all 5 visits)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study to Determine the Bioequivalence of Two Fixed Dose Combination (FDC) Tablet Formulations of Amlodipine and Losartan FDC5/50 and FDC5/100 Under Fasting ConditionsHypertensionNCT01797926GlaxoSmithKline102
已完成
1 期
A Study to Compare Pharmacokinetics of GB1211PharmacokineticsNCT05747573Galecto Biotech AB13
招募中
不适用
Study to Assess PK, PD, Nicotine Extraction, Palatability, Subjective Effects of Nicotine Pouches - Daily Nicotine UsersNicotine Use DisorderNCT06170138Amplicon AB12
已完成
1 期
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male SubjectsType 2 Diabetes MellitusNCT01941199Dong-A Pharmaceutical Co., Ltd.36
已完成
3 期
Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric CancerGastric CancerNCT00202969Taiho Pharmaceutical Co., Ltd.180