NCT00714337已完成1 期
A Phase I, Single-Centre, Randomised, Open-Label, Five-Way Cross-Over Formulation- and Food-Effect Study in Healthy Volunteers to Assess the Pharmacokinetics of AZD1386 After Single Doses of Two Oral Solid Formulations and an 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
- 12
- 主要终点
- PK variables
研究概览
简要总结
To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution.
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females must be non-fertile (Amenorrhea and no pregnancy in the last 12 months prior to enrolment or documentation of being irreversible surgically sterile).
- •Healthy male volunteers with BMI between 18 and 30 kg/m2
- •Clinical normal physical findings, including blood pressure, pulse rate above 45 bpm, ECG, and laboratory assessments.
- •Normal QTc interval on baseline ECG, between 360-450 msec, according to the Fridericia formula.
排除标准
- •History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity as judged by the Investigator.
- •Requirement of concomitant medication during the study, excluding hormone replacement therapy (HRT) or use of drugs with enzyme inducing properties with 3 weeks of first dose
- •Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before first administration of study drug
- •A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives and who have a QT/QTc <360 ms
研究组 & 干预措施
1
Experimental
fasting state
干预措施: AZD1386 (Drug)
2
Experimental
fasting state
干预措施: AZD1386 (Drug)
3
Experimental
non-fasting state
干预措施: AZD1386 (Drug)
4
Experimental
fasting state
干预措施: AZD1386 (Drug)
5
Experimental
non-fasting state
干预措施: AZD1386 (Drug)
结局指标
主要结局
PK variables
时间窗: Frequent sampling occasions during study days
次要结局
- Safety variables (adverse events, blood pressure, pulse, safety lab)(During the whole treatment period)
研究者
相似试验
已完成
1 期
AZD1981 Bioavailability Study of Intravenous (IV) and Oral FormulationsHealthyPostmenopausalSurgically Sterile WomenNCT00918398AstraZeneca14
已完成
1 期
To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy VolunteersParkinson's DiseaseNCT01457807AstraZeneca24
已完成
1 期
To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.Healthy VolunteersNCT01951599AstraZeneca35
已完成
1 期
AZD4635 Relative Bioavailability StudyHealthy VolunteersNCT03710434AstraZeneca21
已完成
1 期
Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy ParticipantsCorona Virus DiseaseNCT05166421AstraZeneca224