KCT0003351已完成未知
A phase 1, randomized, open-label, single dose, 3-treatment, 3-period Williams-design to assess the pharmacokinetic characteristics and food effect of mosapride citrate controlled-release tablets compared with mosapride citrate immediate-release tablets in healthy male subjects.
Korea United Pharm0 个研究点目标入组 48 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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 Study
入排标准
- 年龄范围
- 20(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •1. Healthy male adult.
- •2. Total body weight is at least 55 kg and within 20% of ideal body weight.
- •3. No morbid conditions or findings under medical examinations. No congenital disorders or chronic diseases.
- •4. No clinically relevant abnormalities identified by laboratory tests.
- •5. A personally signed and dated informed consent documents indicating that the subject has been informed of all pertinent aspects of the trial.
排除标准
- •1. Any previous history of intolerance or allergic reaction to mosapride citrate, gastroprokinetcs, or antispasmodics.
- •2. Blood pressure equal to or more than 145 mmHg systolic or 95 mmHg diastolic. blood pressure equal to or less than 100 mmHg systolic or 50 mmHg diastolic, or pulse rate exceeding 100 bpm.
- •3. Evidence or history of clinically significant diseases.
- •4. 12-lead ECG demonstrating atrial ectopy, ventricular ectopy, atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, multifocal ventricular ectopic beats, or QTc > 450 msec.
- •5. Gastriintestinal disorders affecting the abosorption of investigational drugs.
- •6. Treatments for peptic ulcer or gastrointestinal tract bleeding, or clinically related histories within 2 months prior to the first dose.
- •7. Regular alcohol consumption exceeding 21 units/week. Unable to stop drinking or smoking during the study.
- •8. Treatments with an investigational drug within 3 months prior to the first dose of trial medications.
- •9. Whole blood donations within 2 months, or apheresis within 1 month prior to the first dose of investigational products.
- •10. Use of cytochrome P450 inducers or inhinitors within 1 month prior to the first dose of trial medications.
- •11. Use of prescription or herbal medicines within 2 weeks, or non-prescription drugs within 1 week prior to the first dose of study drugs.
- •12. Psychiatric illnesses, drug abuse, alcohol abuse.
- •13. Subjects considered ineligible by investigators.
- •14. Intake of grapefruit juice or grapefruit-containing products within 1 week prior to the first dose of investigational drugs.
- •15. History of drug abuse.
- •16. Galatose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
研究者
相似试验
已完成
不适用
A phase 1 study to evaluate the effect of food on the pharmacokinetics of BS-112 and to compare the pharmacokinetics and safety of BS-112 to BY-XRT in healthy subjectsKCT0006383Bio-Synectics36
尚未招募
不适用
A Phase I randomized, open-label, single dose, 3-period crossover trial in healthy subjects to evaluate the relative oral bioavailability of the 25 mg and 100 mg tablets of TMC125.AIDSHIV10047438NL-OMON30258TIBOTEC Pharmaceuticals Ltd., Little Island, Co. Cork; Ireland in Nederland vertegenwoordigd door Janssen-Cilag BV36
已完成
1 期
A study to investigate the effects of food and administration of different forms of mavodelpar on the safety and concentration of mavodelpar in the bloodHealthy VolunteersISRCTN85791974Reneo Pharma Ltd (United Kingdom)32
已完成
1 期
A study to measure how much of the study drug GDC-6036 is absorbed and the effect of food on absorption in healthy participantsISRCTN10450075Genentech, Inc.18
已完成
不适用
A Phase I, open-label, randomized, single-dose, two-way crossover study to compare the relative bioavailability of GLPG2737 given as a capsule formulation and an oral suspensioCystic fibrosismucoviscidosisthick mucus disease10027664NL-OMON45861Galapagos NV12