NCT02561884Unknown1 期
A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study on a Olostar Tab Versus Two Co-administered Reference Products Olmesartan Medoxomil and Rosuvastatin Calcium in Healthy Volunteers
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 58 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 58
- 主要终点
- AUC
研究概览
简要总结
To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs Olmetec and Crestor.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 18.5 and ≤ 30.0 kg/m
- •No clinically significant findings in a 12-lead electrocardiogram (ECG)
- •Age 18-60 years at screening
排除标准
- •History of severe allergy or allergic reactions to the IMPs or related drugs
- •History of serious clinical illness that can impact fate of drugs including major surgery
研究组 & 干预措施
AB
Experimental
Olostar Tab. followed by Olmetec and Crestor
干预措施: Olostar Tab. (Drug)
AB
Experimental
Olostar Tab. followed by Olmetec and Crestor
干预措施: Co-administration of Olmetec and Crestor (Drug)
BA
Experimental
Olmetec and Crestor followed by Olostar Tab.
干预措施: Olostar Tab. (Drug)
BA
Experimental
Olmetec and Crestor followed by Olostar Tab.
干预措施: Co-administration of Olmetec and Crestor (Drug)
结局指标
主要结局
AUC
时间窗: 0~72hr
Cmax
时间窗: 0~72hr
次要结局
未报告次要终点
研究者
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