NCT00770302已完成1 期
An Open Label, Pharmacokinetic Study of Single and Multiple Doses of 5 mg Saxagliptin in Healthy Chinese Subjects Living in China
适应症
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
- 34
- 试验地点
- 1
- 主要终点
- Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin
研究概览
简要总结
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and its pharmacologically active metabolite, BMS-510849, following single and multiple oral doses of 5 mg saxagliptin in healthy Chinese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women (not of childbearing potential) of Chinese ethnicity
- •Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2
- •Must have normal physical examination, laboratory values, ECG, pulse and blood pressure unless the investigator considers an abnormality to not be clinically significant.
排除标准
- •History of clinically significant hypoglycaemia (low blood sugar levels)
- •Women who are pregnant or breastfeeding
结局指标
主要结局
Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin
时间窗: Multiple timepoints during 9 days
次要结局
- Pharmacokinetic variables for saxagliptin's active metabolite BMS-510849 after single and multiple oral doses of 5 mg saxagliptin(Multiple time points during 9 days)
- Safety variables (adverse events reported, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests after single and multiple oral doses of 5 mg saxagliptin(Multiple time points during 10 days (including measurements before dosing))
研究者
研究点 (1)
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