NCT01183585已完成1 期
A Single Center, Open-label, Fixed Sequence, Two-period Study to Investigate the Effect of RO4917838 on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers
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
- 18
- 主要终点
- To determine the effect of multiple doses of RO4917838 on single-dose pharmacokinetics of Rosuvastatin
研究概览
简要总结
This single centre, open-label study will investigate the effect of RO4917838 on the pharmacokinetics of Rosuvastatin, a frequently co-prescribed drug in healthy volunteers. Healthy volunteers will receive multiple oral doses of RO4917838 and single oral dose of Rosuvastatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult healthy volunteers, 18 to 65 years of age
- •A body mass index (BMI) between 18 to 30 kg/m2
排除标准
- •History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis (Gilbert's Syndrome is allowed)
- •Diseases or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs
研究组 & 干预措施
1
Experimental
干预措施: RO4917838 and Rosuvastatin (Drug)
结局指标
主要结局
To determine the effect of multiple doses of RO4917838 on single-dose pharmacokinetics of Rosuvastatin
时间窗: 30 days
次要结局
- To evaluate the safety and tolerability of single-dose Rosuvastatin and multiple-dose RO4917838 alone and in combination(30 days)
- To explore the effect of single-dose Rosuvastatin on steady-state pharmacokinetics of RO4917838(30 days)
研究者
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