NCT00957437已完成1 期
A Phase I, Randomised, Open, Single-centre Study to Evaluate the Pharmacokinetics of Different Extended-release Formulations of AZD1305 When Given as Single and Repeated Oral Doses to Healthy Male Volunteers
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
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed, written and dated informed consent prior to any study specific procedures.
- •Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
排除标准
- •History or presence of any clinically significant disease or disorder in the opinion of the investigator.
- •Use of nicotine in the last 4 weeks before screening and not more than 7 cigarettes per week (equivalent to 1 nicotine patch or 7 nicotine gums per week) before then. There will be no smoking until follow-up visit.
- •Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
研究组 & 干预措施
Part A: 3 way crossover
Experimental
AZD1305: ER test formulation 1 (w/wo food) and reference formulation
干预措施: AZD1305 (Drug)
Part B1: single arm
Experimental
AZD1305: ER test formulation 1
干预措施: AZD1305 (Drug)
Part B2: 3 way crossover
Experimental
AZD1305: ER test formulation 2 (w/wo food) and reference formulation
干预措施: AZD1305 (Drug)
结局指标
主要结局
Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma
时间窗: From predose until 48 hours post last dose
次要结局
- Adverse Events, ECG variables, vital signs, physical examination, laboratory variables and weight(Frequent safety measurements during the study, from screening period to follow-up)
研究者
研究点 (1)
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