A Single-center, Randomized, Open-label, Four Treatments, Four Periods, Four Sequence, Four-way Crossover Study to Explore the Pharmacokinetic Performance of Dalcetrapib and Atorvastatin Fixed Dose Combination Prototype Formulations in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Plasma Concentration of Dalcetrapib Active Form
研究概览
简要总结
A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, 18 to 55 years of age, inclusive
排除标准
- •Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the patient
- •Clinically significant abnormal laboratory values
研究组 & 干预措施
A
RO5317116/F01 bilayer tablet
干预措施: atorvastatin (Drug)
A
RO5317116/F01 bilayer tablet
干预措施: dalcetrapib (Drug)
B
RO5317116/F03 bilayer tablet
干预措施: atorvastatin (Drug)
B
RO5317116/F03 bilayer tablet
干预措施: dalcetrapib (Drug)
C
RO5317116/F04 active-coated tablet
干预措施: atorvastatin (Drug)
C
RO5317116/F04 active-coated tablet
干预措施: dalcetrapib (Drug)
D
RO4607381/F49 tablet
干预措施: atorvastatin (Drug)
D
RO4607381/F49 tablet
干预措施: dalcetrapib (Drug)
结局指标
主要结局
Plasma Concentration of Dalcetrapib Active Form
时间窗: 3 days
Plasma Concentration of Atorvastatin
时间窗: 3 days
次要结局
- Safety: Incidence of Serious Adverse Events(9 weeks)
- Plasma Concentration of Atorvastatin Metabolites(3 days)