The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity
研究概览
简要总结
The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and drug-drug interactions of sitagliptin therapy.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women between 21 to 60 years of age will be recruited to participate in this study.
- •Subjects will be eligible if metabolic, renal, hepatic, and hematological laboratory tests are within normal limits.
排除标准
- •Subjects will be excluded from the study if they have a current or past history of cardiovascular, hepatic, endocrine (e.g., diabetes), renal, pancreatic, gastrointestinal, pulmonary, immunologic, hematologic, or neurologic disease.
研究组 & 干预措施
ABCB1 Group 3
ABCB1 TTT/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
干预措施: Sitagliptin (Drug)
ABCB1 Group 1
ABCB1 CGC/CGC genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
干预措施: Sitagliptin (Drug)
ABCB1 Group 1
ABCB1 CGC/CGC genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
干预措施: atorvastatin (Drug)
ABCB1 Group 2
ABCB1 CGC/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
干预措施: Sitagliptin (Drug)
ABCB1 Group 2
ABCB1 CGC/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
干预措施: atorvastatin (Drug)
ABCB1 Group 3
ABCB1 TTT/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
干预措施: atorvastatin (Drug)
结局指标
主要结局
Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
Sitagliptin Monotherapy: Sitagliptin Maximum Plasma Concentration (Cmax)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
Sitagliptin Monotherapy: Sitagliptin Renal Clearance (CLr)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
次要结局
- Sitagliptin + Atorvastatin: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose)
- Sitagliptin + Atorvastatin: Sitagliptin Maximum Plasma Concentration (Cmax)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose)
- Sitagliptin + Atorvastatin: Sitagliptin Renal Clearance (CLr)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose)