NCT00426452已完成1 期
A Phase IB, Open Label, Single Center, Drug-drug Interaction Study of Oral 1250 mg of PTK787/ZK 222584 Administered Under Fasting and Fed Conditions With a Proton-pump Inhibitor (Omeprazole) in Healthy Sterile or Postmenopausal Female Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 24
- 主要终点
- Assess the effect of multiple doses of a proton-pump inhibitor on the pharmacokinetics of a single dose of Vatalinib under fasting and fed conditions.
研究概览
简要总结
This study will determine the effect of acidic drugs such as proton-pump inhibitors on the pharmacokinetics of Vatalinib under fasting and fed conditions.
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy female
- •Surgically sterile or post-menopausal
- •At least a weight of 50 kg and have a body mass index (BMI) ≤33.0
- •Non-smokers or those who smoke 25 cigarettes or less per day
排除标准
- •Use of certain prescription and over the counter drugs
- •Having received an investigational drug within 30 days prior to dosing
- •Donation of plasma or donation or loss of whole blood prior to administration of the study medication
- •Any clinically significant laboratory tests
- •Abnormal cardiac function
- •A positive test for HIV, Hepatitis B or C
- •A positive alcohol test or drug test
- •Known allergy to Vatalinib or Omeprazole
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism and excretion or drugs.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Assess the effect of multiple doses of a proton-pump inhibitor on the pharmacokinetics of a single dose of Vatalinib under fasting and fed conditions.
次要结局
- Safety of a single dose of Vatalinib before and after a proton-pump inhibitor under fasting and fed conditions as assessed by adverse events, laboratory values, electrocardiograms, and vital signs.
研究者
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未知
不适用
Therapeutic study of the proton- pump inhibitors resistant patients with Non-Erosive Reflux Diseaseon-Erosive Reflux Disease (NERD)Digestive SystemNon-Erosive Reflux Disease (NERD)ISRCTN82345975Shimane University, Second Department of Internal Medicine (Japan)149