ISRCTN16720571已完成不适用
The effect of varying degrees of renal impairment on the single dose pharmacokinetic profile of orally administered lurasidone: a phase I study
Dainippon Sumitomo Pharma Europe Ltd (UK)0 个研究点目标入组 33 人开始时间: 2009年2月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •All subjects:
- •1. Male or female, between 18 and 75 years of age inclusive
- •2. Body mass index (BMI) between 18 and 32 kg/m^2, and minimum body weight of 50 kg
- •3. Written informed consent
- •4. Able to comply with all aspects of protocol
- •Renal impairment subjects:
- •5. Renal impairment based on Cockcroft-Gault estimation of creatinine clearance (CrCl)
- •6. Renal disease is deemed stable by investigator
- •7. Pre-study clinical laboratory findings are within normal range
- •Normal renal function subjects:
- •8. Subject has normal renal function based on Cockcroft-Gault estimation
- •9. Subject is in good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG) and standard laboratory tests
排除标准
- •1. Clinically significant illness in 4 weeks before screening
- •2. Shows evidence of clinical significant underlying medical condition
- •3. End-stage renal disease and is receiving dialysis
- •4. Any disorder which may alter drug absorption, distribution, metabolism and excretion
研究者
相似试验
已完成
不适用
Influence of renal dysfunction on the outcomes of hepatectomy for hepatocellular carcinomaHepatocellular carcinomaJPRN-UMIN000041749Hiroshima University238
已完成
1 期
Influence of Different Degrees of Renal Impairment on the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BIBT 986 BS in Subjects With Normal Renal Function and Patients With Different Degrees of Renal ImpairmentHealthyNCT02254070Boehringer Ingelheim23
进行中（未招募）
1 期
Evaluation of the impact of renal function on the pharmacokinetics of hydroxyurea (Siklos®) in patients with sickle cell disease with normal renal function, with hyperfiltration, or with renal failure. DARH studySiklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic sickle cell syndrome.MedDRA version: 17.1Level: LLTClassification code 10040643Term: Sickle cell crisisSystem Organ Class: 100000004851EUCTR2014-005033-31-FRAddmedica S.A.S
进行中（未招募）
不适用
Systemic effects of mild renal insufficiency: the relation between forearm blood flow and ADMA.hypertensionmild renal insufficiencyEUCTR2007-005546-20-NLacademisch ziekenhuis Maastricht
尚未招募
不适用
Systemic effects of mild renal insufficiency: the relation between forearm blood flow and ADMA.deterioration of kidney functionrenal dysfunction1003843010057166NL-OMON33594Academisch Ziekenhuis Maastricht75