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临床试验/NCT02387619
NCT02387619已完成1 期

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers

Jeil Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
41
试验地点
1
主要终点
AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine

研究概览

简要总结

A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

详细描述

A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 19~55 years healthy male
  • Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
  • Subjects who agree to keep contraceptive methods during the clinical trial.

排除标准

  • Subjects who are allergic to investigational drug.
  • Subjects who have a medical history which can affect the clinical trial.
  • Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
  • Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

研究组 & 干预措施

Group 1 of part 1

Experimental

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2

干预措施: Rosuvastatin (Drug)

Group 1 of part 1

Experimental

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2

干预措施: Rosuvastatin and Telmisartan/Amlodipine (Drug)

Group 2 of part 1

Experimental

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2

干预措施: Telmisartan/Amlodipine (Drug)

Group 2 of part 1

Experimental

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2

干预措施: Rosuvastatin and Telmisartan/Amlodipine (Drug)

Group 1 of part 2

Experimental

Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2

干预措施: Rosuvastatin (Drug)

Group 1 of part 2

Experimental

Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2

干预措施: Rosuvastatin and Telmisartan/Amlodipine (Drug)

Group 2 of part 2

Experimental

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2

干预措施: Telmisartan/Amlodipine (Drug)

Group 2 of part 2

Experimental

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2

干预措施: Rosuvastatin and Telmisartan/Amlodipine (Drug)

结局指标

主要结局

AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine

时间窗: 72hours, 144hours

次要结局

  • AUClast,ss of Rosuvastatin(72hours)
  • AUCinf,ss of Rosuvastatin(72hours)
  • Tmax,ss of Rosuvastatin(72hours)
  • t1/2 of Rosuvastatin(72hours)
  • AUClast,ss of Telmisartan, Amlodipine(144hours)
  • AUCinf,ss of Telmisartan, Amlodipine(144hours)
  • Tmax,ss of Telmisartan, Amlodipine(144hours)
  • t1/2 of Telmisartan, Amlodipine(144hours)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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