Open-label, Single Dose, Tolerability, Pharmacokinetic/Pharmacodynamics and Safety Study of Dabigatran Etexilate Given at the End of Standard Anticoagulant Therapy in Children Aged Less Than 1 Year Old
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate
研究概览
简要总结
The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year.
详细描述
Purpose:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 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
dabigatran
open label arm with dabigatran oral liquid formulation as single dose
干预措施: dabigatran (Drug)
结局指标
主要结局
Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate
时间窗: 2 hours (h) and 12h after drug administration on day 1
Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate.
Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
时间窗: 2 h, and 12 h after dosing on day 1
Central measurement: The mean activated partial thromboplastin time (aPTT) coagulation time at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.
Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
时间窗: 2 h, and 12 h after dosing on day 1
Central measurement: The mean of Ecarin Clotting Time (ECT) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.
Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
时间窗: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
Central measurement: The mean Ecarin Clotting Time (ECT) ratio at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation. ECT ratio= ECT(Post dose)/ECT(baseline), The mean of ECT ratio is presented.
Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
时间窗: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
Central measurement: The mean of dTT (AntiFactor IIa activity) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation. dTT ratio= dTT(post dose)/dTT(baseline). The mean of dTT ratio is presented.
Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
时间窗: 2 h, and 12 h after dosing on day 1
Central measurement: The mean of dTT (AntiFactor IIa activity) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.
Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
时间窗: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
Central measurement: The mean aPTT (activated partial thromboplastin time) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation. aPTT ratio= aPTT (post dose)/aPTT (baseline). The mean of aPTT ratio is presented.
次要结局
- PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values.(baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1)
- PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values.(baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1)
- PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values.(baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1)
- Incidence of All Bleeding Events (Major, CRNM and Minor) During the Treatment Period.(Within two days after the administration of trial medication, up to 3 days)
- Incidence of All AEs During the Treatment Period(Within two days after the administration of trial medication, up to 3 days)
- Global Assessment of Acceptability and Tolerability of Study Medication(Day 1 (immediately after dosing))