An Open Label, Phase I Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Linagliptin (BI 1356) 5 mg After Single and Multiple Oral Administration in Patients With Type 2 Diabetes Mellitus of African American Origin for 7 Days
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Linagliptin: AUC_τ,ss
研究概览
简要总结
The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of African American origin.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
linagliptin
Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation
干预措施: linagliptin QD (once daily) for 7 days (Drug)
结局指标
主要结局
Linagliptin: AUC_τ,ss
时间窗: 24 hours
area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval
Linagliptin: C_max,ss
时间窗: 24 hours
maximum concentration of linagliptin in plasma at steady state
DPP-4 Inhibition: E_24,ss
时间窗: One single measurement 24 h after drug administration under steady state conditions
Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))\*100%, where 'activity' is the activity of the DPP-IV enzyme.
次要结局
- Treatment Emergent Adverse Events(21 days)
- Linagliptin: AUC_0-24(24 hours)
- Linagliptin: C_max(24h)
- Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event(21 days)
- DPP-4 Inhibition: E_24(One single measurement 24 h after drug administration)
- Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities(21 days)