An Open-label, Randomised, 3-period, 3-treatment, Crossover, Single-centre, Single-dose, Bioavailability Study With Alternative Methods of Administration of Crushed Ticagrelor Tablets, 90 mg, Compared to Whole Ticagrelor Tablets, 90 mg, in Healthy Volunteer
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
- Description of the pharmacokinetic(PK) profile in terms of AUC of the active metabolite of ticagrelor
研究概览
简要总结
Study to investigate if the uptake of Ticagrelor into the body differs depending on method of administration.
详细描述
Study to evaluate the bioavailability of the crushed ticagrelor tablets when administered orally or through nasogastric tubes compared to whole ticagrelor tablets given orally
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venepuncture
- •Have a body mass index between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg (110 pounds [lbs]) and no more than 100 kg (220 lbs).
- •Provision of signed and dated, written informed consent prior to any study specific procedures
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- •History of haemophilia, von Willebrand's disease, lupus anticoagulant or other diseases/syndromes that can either alter or increase the propensity for bleeding
- •A personal history of vascular abnormalities including aneurysms; a personal history of severe haemorrhage, haematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 3 months prior to the screeening visit; or history suggestive of peptic ulcer disease
- •History of frequent and/or significant nose bleed or clinically significant non traumatic bleed, bruise/haematoma or any other clinically significant bleeding risk, as judged by the Investigator
研究组 & 干预措施
C
Dispersed ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the the stomach
干预措施: Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube (Drug)
B
Ticagrelor 90 mg tablet crushed and suspended in water
干预措施: Ticagrelor 90 mg tablet crushed (Drug)
A
Ticagrelor 90 mg as a whole tablet
干预措施: Ticagrelor 90 mg whole tablet (Drug)
结局指标
主要结局
Description of the pharmacokinetic(PK) profile in terms of AUC of the active metabolite of ticagrelor
时间窗: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of maximum plasma concentration (Cmax) of ticagrelor
时间窗: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of Cmax of the active metabolite of ticagrelor
时间窗: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of plasma concentration-time curve (AUC) of ticagrelor
时间窗: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
次要结局
- Description of the safety profile in terms of Electrocardiogram (ECG)(ECGs at screening, Day 3 and follow-up)
- Description of the safety profile in terms of adverse events (AE)(From first dose through to the follow-up visit.)
- Description of the safety profile in terms of laboratory variables(Safety labs at screening, Day -1, Day 3 (48 hours after treatment) and follow-up)
- Description of the safety profile in terms of vital signs(Vital signs at screening, pre-dose, 1 h, 3, 6, 12 and 24 hours post-dose, Day 3 for all treatment periods and follow-up)
- Description of the safety profile in terms of physical examination findings(Physical examination at screening, pre-dose, Day 3 and follow-up)