Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet Compared to Conventional Oral Aspirin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 主要终点
- Plasma-concentration time data of salicylic acid
研究概览
简要总结
The objective of the study is to compare the pharmacokinetics and pharmacodynamics of a new sublingual formulation of aspirin with that of oral aspirin when administered to healthy volunteers under fasting conditions. The test product is sublingual aspirin 80 mg manufactured by Vita Green Health Products Co. Ltd, Hong Kong and the reference product is oral aspirin 80mg tablet manufactured by Synco (HK) Ltd, Hong Kong.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, 18 to 55 years of age
- •Body mass index between 18-27kg/m2
- •Accessible vein for blood sampling
- •High probability for compliance and completion of the study
- •No significant abnormalities in general physical examination
- •Subjects must agree to take effective contraceptive methods to prevent his partner pregnant during the time of first dose of study medication until one week of last dose administration
排除标准
- •History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to screening
- •Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test at the discretion of the investigator
- •Positive results for hepatitis B at screening
- •Moderate smoker (on average more than 2 cigarettes a day within 1 month prior to the start of first dosing)
- •Moderate consumption of alcohol (on average more than one drink per day within 1 month prior to start of first dosing)
- •Blood donation of more than 350 ml within 4 weeks prior to start of first drug dosing
- •Treatment of aspirin within 4 weeks before first dosing
- •Volunteer in any other clinical drug study within 2 months prior to start of first dosing
- •Hypersensitivity to aspirin or other drug in its class
研究组 & 干预措施
Healthy volunteer
Sublingual or oral aspirin 80mg tablet, single dose, two-treatment, two-period, two-sequence, randomized, crossover design, with washout 1-2 weeks
干预措施: Sublingual aspirin (Drug)
Healthy volunteer
Sublingual or oral aspirin 80mg tablet, single dose, two-treatment, two-period, two-sequence, randomized, crossover design, with washout 1-2 weeks
干预措施: Oral aspirin (Drug)
结局指标
主要结局
Plasma-concentration time data of salicylic acid
时间窗: pre dose and up to 24 hour post dose
area under the plasma concentration-time curve from time zero to last measurable concentration time point for sublingual versus oral aspirin 80mg
次要结局
- Terminal phase elimination rate constant of salicylic acid(pre dose and up to 24 hour post dose)
- Plasma concentration time data of thromboxane B2(pre dose and up to 24 hour post dose)
- Time to reach peak plasma concentration of salicylic acid(pre dose and up to 24 hour post dose)
- Terminal elimination half-life of salicylic acid(pre dose and up to 24 hour post dose)
- Platelet aggregation by impedance aggregometry(pre dose and up to 360 minutes post dose)
- Peak plasma concentration of salicylic acid(pre dose and up to 24 hour post dose)
研究者
Dr. Elaine Chow
Clinical Assistant Professor
Chinese University of Hong Kong