EUCTR2009-015398-11-NL进行中（未招募）1 期
Pharmacokinetic and pharmacodynamic profile of rapid-acting insulin injected by needle-free jet-injection - Pharmacology of insulin injected with jet-injection
Radboud University Nijmegen Medical Centre0 个研究点目标入组 48 人开始时间: 2009年9月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria for healthy subjects
- •Age 18-50 years
- •Body-mass index 18-28 kg/m2
- •Blood pressure <160/90 mmHg
- •Inclusion criteria for patients with type 1 diabetes
- •Age 18-50 years
- •Body-mass index 18-28 kg/m2
- •Stable glycaemic control with HbA1c 6.5-9.0%
- •Duration of diabetes >1 year
- •Blood pressure <160/90 mmHg
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria for healthy subjects
- •Inability to provide informed consent
- •Chronic use of medication other than oral contraceptives or thyroid hormone replacement therapy (with stable euthyroidism for at least 3 months)
- •Type 2 diabetes in first-degree relatives
- •History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty)
- •Exclusion criteria for patients with type 1 diabetes
- •Inability to provide informed consent
- •Chronic use of medication other than insulin, oral contraceptives, thyroid hormone replacement therapy (with stable euthyroidism for at least 3 months), or low-dose angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) treatment
- •Macroalbuminuria, i.e. urinary albumin excretion >200 ?g/min in collected urine sample or urinary albumin-to-creatinine ratio >300 mg/g in spot urine sample
- •Symptomatic diabetic neuropathy
- •Proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion)
- •History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty)
研究者
相似试验
已完成
不适用
Pharmacokinetic and pharmacodynamic profile of rapid-acting insulin injected by needle-free jet-injectiojuvenile diabetes10018424type 1 diabetes mellitusNL-OMON32491niversitair Medisch Centrum Sint Radboud48
尚未招募
不适用
Study of Ranolazine table In-Vivo Bioequivalence in healthy volunteersIn this study, the disease is not examined. Subject bioequivalence test and reference tablets Ranolase studied..IRCT20200105046010N13Arena life science24
进行中（未招募）
不适用
A pharmacokinetic and pharmacodynamic study of recombinant human IGF-I (rhIGF-I) in three boys with ALS deficiency, and insulin sensitivity and bone density in patients and heterozygous first-degree relatives. - ALS deficiency: insulin resistance, bone strength & response to rhIGF1ALS (acid label subunit) deficiencyMedDRA version: 12.1Level: LLTClassification code 10056438Term: Growth Hormone DeficiencyEUCTR2010-019296-30-GBniversity Hospital Birmingham NHS Foundation Trust
进行中（未招募）
1 期
Pharmacokinetic and pharmacodynamic evaluation of linezolid administered intravenously in MRSA-positive, morbidly obese patients with pneumonia.EUCTR2012-005127-33-BEniversity Ghent20
已完成
不适用
Pharmacokinetic and pharmacodynamic modelling of routinely used off label drugs in premature neonates10039911Pijn en sedatiePrematurity10028971NL-OMON44214Erasmus MC, Universitair Medisch Centrum Rotterdam600