A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also investigate drug interaction between separate and combination administration.
Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day administration, 16 days washout after 6th day of administration.
The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over design during 2 each period.
The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a cross-over design during 2 each period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female aged 20 to 50 with a body mass index(BMI) between 19 and 27 kg/m2
- •Acceptable medical history, physical examination, laboratory tests and EKG, during screening
- •Provision of signed written informed consent •20~50 yrs old, healthy Korean Subjects
排除标准
- •1.History of and clinically significant disease 2.Sitting blood pressure meeting the following criteria at screening: 150 ≤ systolic blood pressure ≤90 (mmHg) and 95 ≤ diastolic blood pressure ≤ 50 (mmHg) amd 100 ≤ Heart rate ≤ 40
- •A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
- •Administration of other investigational products within 90 days prior to the first dosing.
- •Administration of herbal medicine within 30 days or administration of ethical drugs within 14 days or administration of over-the-counter (OTC) drugs within 7 days prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
- •6.Have AST(SGOT) or/and ALT(SGPT) > 3 times of normal upper limit at the time of screening
- •Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
研究组 & 干预措施
1
This arm is consist of 12 subject. Crestor 20mg alone for 6 day during period 1. Crestor 20mg and Micardis 80mg for 6 day during period 2.
干预措施: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) (Drug)
2
This arm is consist of 12 subject. Crestor 20mg and Micardis 80mg for 6 day during period 1. Crestor 20mg alone for 6 day during period 2.
干预措施: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) (Drug)
3
This arm is consist of 12 subject. Micardis 80mg alone for 6 day during period 1. Crestor 20mg and Micardis 80mg for 6 day during period 2.
干预措施: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) (Drug)
4
This arm is consist of 12 subject. Crestor 20mg and Micardis 80mg for 6 day during period 1. Micardis 80mg alone for 6 day during period 2.
干预措施: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) (Drug)
结局指标
主要结局
AUC
时间窗: 72hr
AUC τ,ss of Rosuvastatin and Telmisartan
Cmax
时间窗: 72hr
Cmax,ss of Rosuvastatin and Telmisartan
次要结局
- AUC(72hr)
- Tmax(72hr)
- t1/2(72hr)
- Cmin(72hr)
- Cmax(72hr)