NCT00844324已完成1 期
A Single Dose, 2-Period, Cross-over, Bioequivalence Study in Healthy Subjects to Evaluate the Proposed Commercial Oral Suspension of Candesartan Cilexetil
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
- 36
- 试验地点
- 1
- 主要终点
- PK (Candesartan cilexetil)
研究概览
简要总结
This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial oral suspension of candesartan cilexetil (1 mg/mL) and a single 32 mg dose of the candesartan cilexetil oral suspension (1.6 mg/mL) used in the paediatric program.
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
- •Provision of informed consent prior to any study specific procedures
- •Body mass index (BMI) 19-27 kg/m2 calculated from height and weight at the Screening visit
- •Clinically normal physical findings including ECG and safety laboratory values at the Screening visit and on Day -1 of each treatment period, including negative results for drugs-of-abuse, alcohol, Hepatitis B, Hepatitis C and HIV.
排除标准
- •History of significant mental, cardiac, renal, hepatic or significant gastrointestinal disease (that may affect the rate and extent of absorption of the IP), as judged by the Investigator
- •Any condition which could modify the absorption of the IPs
- •Previous randomisation of treatment in the present study
- •History or symptoms and signs of ongoing severe allergic disease/hypersensitivity
研究组 & 干预措施
A
Experimental
Candesartan cilexetil 1mg/mL
干预措施: Candesartan cilexetil (Drug)
B
Experimental
Candesartan cilexetil 1.6mg/mL
干预措施: Candesartan cilexetil (Drug)
结局指标
主要结局
PK (Candesartan cilexetil)
时间窗: Collected at pre-dose and at selected time points; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30 and 36 hours post-dose
次要结局
- Safety variables (adverse events, ECG, vital signs, safety laboratory)(During the whole treatment period)
研究者
研究点 (1)
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