NCT00766025已完成1 期
A Phase I, Open Label, Parallel Group, Single and Multiple Dose Study in Taiwanese Subjects Identified as CYP2C19 Poor Metabolizers or Extensive Metabolizers Receiving 20 Milligrams of Rosuvastatin Calcium
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood levels for assessment of pharmacodynamic (lipid) parameters
研究概览
简要总结
The main purpose of this study is to examine Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers while taking single and multiple dosing a rosuvastatin calcium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must have blood drawn for genotyping (determination of EM or PM of CYP2C19, determination of OATP-C1B1, BCRP 421C>A, and CYP2C
- •Males and females aged 20-65, inclusive
- •Women who are surgically sterilized, post-menopausal for at least one year, or not pregnant and/or lactating. Women of childbearing potential must be willing to abstain from sexual activity or use an effective contraception as outlined in protocol.
排除标准
- •Subjects with deoxyribonucleic acid (DNA) that codes for OATP-C 1B1 *5 and *15, BCRP 421C>A and/or non wild-type CYP2C9
- •History of adverse drug reaction or hypersensitivity to statins or drugs with a similar chemical structure to rosuvastatin
- •History or presence of gastrointestinal, hepatic, or renal disease or other conditions known to interfere with absorption, distribution, metabolism and excretion (ADME) of drugs
- •Any contraindication determined by review of a detailed medical and drug history, complete physical examination, vital signs, blood chemistry, hematology, and electrocardiogram (ECG)
研究组 & 干预措施
Rosuvastatin Calcium
Experimental
干预措施: Rosuvastatin Calcium (Drug)
结局指标
主要结局
Blood levels for assessment of pharmacodynamic (lipid) parameters
时间窗: Days -1 and 18
Blood levels of rosuvastatin in Taiwanese subjects identified as CYP2CIP poor and extensive metabolizers
时间窗: Scheduled times during the 18 days that the study drug is taken
次要结局
- Safety and tolerability of rosuvastatin in Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers(Screening through completion of the study)
研究者
研究点 (1)
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