An Open-label, Single Center, Parallel-group Study to Compare the Single- and Repeated-dose Pharmacokinetics of Stepwise Increasing Doses of Subcutaneous Certoparin (3000 IU o.d., 3000 IU b.i.d., 8000 IU o.d., and 8000 IU b.i.d.) in Subjects With Severe Renal Insufficiency and Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Plasma aXa-Profile: C0
研究概览
简要总结
This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Certoparin control
Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.
干预措施: Certoparin 3,000 IU Once Daily (Drug)
Certoparin control
Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.
干预措施: Certoparin 8,000 IU Twice a Day (Drug)
Certoparin Renal
Participants receive dose escalation upon medical criteria qualification at each period:
Certoparin 3,000 IU once a day during period 1. Certoparin 3,000 IU twice a day during period 2. Certoparin 8,000 IU once a day during period 3. Certoparin 8,000 IU in the morning and 3,000 IU in the evening during period 4 OR Certoparin 8,000 IU twice a day during period 4.
干预措施: Certoparin 3,000 IU Once Daily (Drug)
Certoparin Renal
Participants receive dose escalation upon medical criteria qualification at each period:
Certoparin 3,000 IU once a day during period 1. Certoparin 3,000 IU twice a day during period 2. Certoparin 8,000 IU once a day during period 3. Certoparin 8,000 IU in the morning and 3,000 IU in the evening during period 4 OR Certoparin 8,000 IU twice a day during period 4.
干预措施: Certoparin 3,000 IU Twice a Day (Drug)
Certoparin Renal
Participants receive dose escalation upon medical criteria qualification at each period:
Certoparin 3,000 IU once a day during period 1. Certoparin 3,000 IU twice a day during period 2. Certoparin 8,000 IU once a day during period 3. Certoparin 8,000 IU in the morning and 3,000 IU in the evening during period 4 OR Certoparin 8,000 IU twice a day during period 4.
干预措施: Certoparin 8,000 IU Once Daily (Drug)
Certoparin Renal
Participants receive dose escalation upon medical criteria qualification at each period:
Certoparin 3,000 IU once a day during period 1. Certoparin 3,000 IU twice a day during period 2. Certoparin 8,000 IU once a day during period 3. Certoparin 8,000 IU in the morning and 3,000 IU in the evening during period 4 OR Certoparin 8,000 IU twice a day during period 4.
干预措施: Certoparin 8,000 IU Twice a Day (Drug)
结局指标
主要结局
Plasma aXa-Profile: C0
时间窗: 5 days
Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by pre-dose trough (C0,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.
Dose regimen, systemic total exposure to aXa (AUC0-τ,ss)
时间窗: 5 days
Dosage regimen (3,000 o.d., 3,000 b.i.d., 8,000 o.d., 8,000 IU aXa in the morning plus 3,000 IU aXa in the evening, or 8,000 b.i.d. IU aXa) that yields a systemic total exposure to aXa (AUC0-τ,ss) in REN-patients similar to that achieved with 8,000 b.i.d. IU aXa in CON-subjects.
Plasma aXa-Profile: Cmax
时间窗: 5 days
Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by maximum (Cmax,ss), aXa comparing REN-patients with matched CON-subjects studied in parallel.
Plasma aXa-Profile: AUC
时间窗: 5 days
Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by total (AUC0-τ,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.
次要结局
未报告次要终点