NCT01681134已完成1 期
A Comparison of Effects of Short-Term Steady State Low Dose Exposure of Extended Release (Advagraf®) and Immediate Release (Prograf®) Formulations of Tacrolimus on Renal Perfusion and Function in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Effective Renal Plasma Flow (ERPF)
研究概览
简要总结
The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.
详细描述
This is a 2 Period study. In Period 1, subjects will be assigned randomly to receive Advagraf® or Prograf® administered once or twice daily, respectively, for a period of 10 days. In Period 2, subjects will be converted from Advagraf® to Prograf® or from Prograf® to Advagraf® for 10 additional days of dosing. Dose adjustments will be made based on the monitoring of drug levels in blood.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian
- •No previous/current history of infection, cerebrovascular, neurological, cardiovascular, endocrine, pulmonary, immunologic or metabolic disease or significant systemic disease, glucose intolerance, gout or hematological disorder
- •Normal 12-lead Electrocardiogram (ECG)
- •Systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg
- •Non-smoker within 3 months prior to screening
- •Willing to abstain from alcohol during the study
排除标准
- •Positive screen for illicit drug or alcohol consumption
- •Subject has hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or history of cancer (excluding completely excised squamous or basal cell carcinoma)
- •Positive tuberculin skin test or known history of tuberculosis infection
- •Known history of serious head injuries, seizures or eating disorders
- •Body Mass Index <18.0 or >30.0
- •History of renal dysfunction, clinically significant creatinine or clinically significant abnormal liver function tests, hemoglobin <130 g/L
- •Plasma donation ≥ 500 mL within 7 days prior to first dose of study drug, donation or whole blood loss 50-499 mL within 30 days or ≥ 499 mL within 56 days prior to first dose of study drug.
- •Drug or alcohol abuse within 1 year prior to study entry
- •Steroid injections within 12 weeks prior to first dose of study drug
- •Live vaccine within 7 days prior to first dose of study drug
研究组 & 干预措施
Advagraf followed by Prograf
Experimental
干预措施: Advagraf® (Drug)
Advagraf followed by Prograf
Experimental
干预措施: Prograf® (Drug)
Prograf followed by Advagraf
Experimental
干预措施: Advagraf® (Drug)
Prograf followed by Advagraf
Experimental
干预措施: Prograf® (Drug)
结局指标
主要结局
Effective Renal Plasma Flow (ERPF)
时间窗: up to Day 20
Estimated by aminohippurate sodium (PAH) clearance
次要结局
- Glomerular Filtration Rate (GFR)(Pre-dose (Day -4), Day 10, Day 20)
研究者
研究点 (1)
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