NCT02251184已完成4 期
Comparison of Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH by the Prior Administration of a Proton-pump Inhibitor: An Open-label 2-way Randomized Cross-over Study in Healthy Male and Female Subjects Age 40-65.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- area under the concentration time curve (AUC0-12)
研究概览
简要总结
Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole administered as the immediate release formulation plus aspirin, under conditions of reduced stomach acidity.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects as determined by results of screening
- •Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- •Age 40 - 65 years, inclusive, at time of Visit 1
- •Stomach pH > 4.0 on three consecutive measurements separated by at least five minutes, measured at Visits 3B and 5B prior to dosing with Aggrenox or dipyridamole-aspirin (DP-ASA)
排除标准
- •Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and considered by the investigator to be of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders considered by the investigator to be of clinical relevance
- •History of gastro-intestinal ulcer, perforation or bleeding
- •Surgery of the gastro-intestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy), neurological disorders, or psychiatric disorders
- •Chronic or relevant acute infections. Screening tests will be performed for HIV, hepatitis B, and hepatitis C
- •History of hypersensitivity to Aggrenox or any of the components or excipients
- •Intake of drugs with a long dominant half-life (>24 hours) 1 month or less prior to Visit 1
- •Use of any drugs which might influence the results of the trial ten days or less prior to Visit 1
- •Participation in another trial with an investigational drug 1 month or less prior to Visit 1
- •Known alcohol abuse
- •Known drug abuse (a drug screening test will be performed at Visits 1, 3, and 5)
- •Blood donation 1 month or less prior to Visit 1
- •Excessive physical activities five days or less prior to Visit 1
- •History of hemorrhagic diathesis
- •History of bronchial asthma
- •Any laboratory value outside the reference range, considered by the investigator to be of clinical relevance
- •For female subjects:
- •Pregnancy
- •Positive pregnancy test
- •No adequate contraception (adequate contraception includes sterilization, intrauterine device, or oral contraceptives)
- •Inability to maintain adequate contraception during the whole study period
研究组 & 干预措施
dipyridamole+aspirin
Active Comparator
immediate release
干预措施: Dipyridamole (Drug)
Aggrenox
Experimental
extended release
干预措施: Aggrenox (Drug)
Aggrenox
Experimental
extended release
干预措施: Lansoprazole (Drug)
dipyridamole+aspirin
Active Comparator
immediate release
干预措施: Aspirin (Drug)
dipyridamole+aspirin
Active Comparator
immediate release
干预措施: Lansoprazole (Drug)
结局指标
主要结局
area under the concentration time curve (AUC0-12)
时间窗: up to 12 hours
次要结局
- maximum observed plasma concentration (Cmax)(up to 3 days)
- terminal half life (t1/2)(up to 3 days)
- area under the concentration time curve 0-48 hours (AUC0-48)(up to 48 hours)
- area under the concentration time curve extrapolated to infinity (AUC0-inf)(up to 3 days)
- number of subjects with clinically significant changes in laboratory findings(up to 17 days)
- time to maximum observed plasma concentration (Tmax)(up to 3 days)
- number of subjects with adverse events(up to 3 weeks)
研究者
相似试验
进行中（未招募）
1 期
The effect of dipyridamole on the pharmacokinetics of metformin.The antihyperglycemic drug metformin and the thrombocyte aggregation inhibitor dipyridamole are often used concomitantly in patients with diabetes who have suffered a transient ischemic attack or stroke. Gastrointestinal absorption of metformin is mediated by the equilibrative nucleoside transporter 4 (hENT4). Dipyridamole has been reported to inhibit hENT4 transport in vitro. Dipyridamole may therefore negatively influence the uptake of metformin from the gastrointestinal tract.MedDRA version: 14.1Level: PTClassification code 10068071Term: Inhibitory drug interactionSystem Organ Class: 10018065 - General disorders and administration site conditionsMedDRA version: 14.1Level: PTClassification code 10013710Term: Drug interactionSystem Organ Class: 10018065 - General disorders and administration site conditionsEUCTR2012-000363-24-NLRadboud University Medical Centre Nijmegen18
招募中
4 期
The effect of dipyridamole on the pharmacokinetics of metformin.geneesmiddeleninteractieDrug interactionNL-OMON37582niversitair Medisch Centrum Sint Radboud18
终止
1 期
Study to Evaluate Pharmacokinetics of Dipyridamole in Three New Formulations of Asasantin ER in Healthy Female and Male SubjectsHealthyNCT02273544Boehringer Ingelheim16
进行中（未招募）
1 期
Comparison between Dipyridamole and Adenosine infusion in the evaluation of intermediate coronary restrictions (stenoses) in the cardiac catheterization laboratorY.Patients with a single = 50% e <75% coronary stenosis (visually extimated) at angiography, in one ore more coronary vessels).EUCTR2010-024485-21-ITFONDAZIONE TOSCANA GABRIELE MONASTERIO75
已完成
3 期
Aggrenox Prevention of Access StenosisKidney FailureNCT00067119National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)649