Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Bioequivalence
研究概览
简要总结
Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (>60 yr) renal transplant recipients
详细描述
12-hour pharmacokinetic investigations performed on each formulation in each patient at steady-state. Patients will be randomized with regards to which formulation to start with. 1-2 weeks between each PK investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal transplant recipients that will receive Tac as part of their immunosuppressive therapy.
- •Recipients 60 years of age or older.
- •Signed informed consent.
排除标准
- •Diabetes mellitus (WHO criteria).
- •Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepin, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.
研究组 & 干预措施
Tacni
Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center
干预措施: Tacrolimus (Drug)
Prograf
Tacrolimus administered as Prograf in according to standard protocol at the transplant center
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Bioequivalence
时间窗: 10 weeks
Bioequivalence will be assessed at steady-state by comparing both AUC(0-12) and Cmax ratios for generic:original-ratios and applying the stricter 90-111% bioequivalence criteria. AUC(0-12) will be assessed by trapezoidal rule and Cmax will be the highest actually measured concentration.
次要结局
- Population model validation(10 weeks)
研究者
Anders Åsberg
Professor
University of Oslo School of Pharmacy