KF2019#1-tutkimus: Verihiutaleiden estäjän Vaikutus kolesterolilääkkeeseen
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration - time curve of rosuvastatin
研究概览
简要总结
The cholesterol-lowering drug rosuvastatin is a substrate of the breast cancer resistance protein (BCRP). BCRP is an efflux transporter expressed e.g. in the small intestine. It limits the oral bioavailability of rosuvastatin by transporting rosuvastatin from enterocytes back to the gut lumen. Inhibition of BCRP can increase rosuvastatin bioavailability and systemic concentrations. Ticagrelor is a platelet aggregation inhibitor used in treatment and prevention of atherothrombotic events. Ticagrelor may inhibit BCRP in humans. This study is aimed to investigate the possible interaction of rosuvastatin with ticagrelor. Ten healthy male or female non-smoking volunteers aged 18-40 years are taken into the study. Primary endpoint is area under the plasma concentration-time curve of rosuvastatin.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Age 18-40
- •Systolic blood pressure ≥100 mmHg
- •Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.
- •Fully vaccinated against COVID-19.
排除标准
- •Significant disease
- •Abnormal result from the Helsinki University Hospital bleeding questionnaire
- •Using oral contraception pills or other regular medication
- •Pregnancy (current or planned) or nursing
- •Participation in any other studies involving investigational or marketed drug products within three months prior to the entry into this study
- •Donation of blood within three months prior to the entry into this study
- •Significant overweight / small or hard-to-find veins
- •Weight < 45 kg
- •BMI < 18.5 kg/m2
- •Insufficient Finnish language skills
研究组 & 干预措施
Placebo
The subjects will be given orally placebo twice a day for 2 days, and a single 10 mg dose of rosuvastatin.
干预措施: Placebo (Drug)
Placebo
The subjects will be given orally placebo twice a day for 2 days, and a single 10 mg dose of rosuvastatin.
干预措施: Rosuvastatin (Drug)
Ticagrelor
The subjects will be given orally 90 mg ticagrelor twice a day for 2 days, and a single 10 mg dose of rosuvastatin.
干预措施: Ticagrelor (Drug)
Ticagrelor
The subjects will be given orally 90 mg ticagrelor twice a day for 2 days, and a single 10 mg dose of rosuvastatin.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Area under the plasma concentration - time curve of rosuvastatin
时间窗: Prior to and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 23, and 47 hours after administration of rosuvastatin
次要结局
- Peak plasma concentration, half-life, time to peak plasma concentration, amount excreted, and renal clearance of rosuvastatin(Prior to and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 23, and 47 hours after administration of rosuvastatin)
研究者
Mikko Niemi
Professor, head physician
Helsinki University Central Hospital