NCT03985319已完成1 期
A Randomized, Open-label, Cross-over Design Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Properties and Safety of YYD601 20mg After Oral Administration in Healthy Adult Subjects (Phase1)
Yooyoung Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年7月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)
详细描述
To evaluate comparatively a characteristics and safety of the PK/PD of single/repeated oral administration YYD601 20mg and Nexium tab 20mg and the effects of food influence the PK/PD of YYD601 20mg in a healthy adults.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers of over 19 years old at the time of screening.
- •Volunteers weighing over 50 kg with ideal body weight (IBW) between -20% ~ 20%
- •Subjects don't have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
- •Subjects evaluated eligible for the study based on the screening test results such as laboratory tests including serology, hematology, blood chemistry and urinalysis, etc and electrocardiogram(ECG).
- •Subejctys who signed on the written informed consent form and comply with study requirements after listening adn fully understanding the details of this study.
排除标准
- •Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole.
- •Who has genetic problem like fructose tolerance, glucose-galctose absorption, deficiency or sucrase-iso maltase deficiency.
- •Medical history or evidence (hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system) that can affect absorption, distribution, metabolism and excretion of a given drug.
- •Subject who has over 141mmHg or under 89mmHg of systolic pressure or over 95mmHg of diastolic pressure in vital sign or over 100 times/min of pulse rate.
- •Who has active liver disease, (AST, ALT, total bilirubin > 2 x LNR), (BUN, creatinine >1.5 x LNR) or clinically abnoramal result at screening test.
- •Creatinine clearance < 80 mL/min (calcaulated by Cockcroft-Gault formula using serum creatinine)
- •History of gastrointestinal disease (e.g., Crohns disease, active peptic ulcer) or gastrointestinal surgery that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)
- •Treatments for peptic ulcer, esophageal disease, Zollinger-Ellison syndrome diagnosis therapy or clinically related histories within 3 months prior to the first dose.
- •Positive 13C-urea breath test
- •A history of serious trauma within 4 weeks, or resection operation (exculding simiple appendectomy or herniorrhaphy) and/or relevant history or laboratory or clinical findings indicative of acute disease.
研究组 & 干预措施
YYD601 20mg
Experimental
Esomeprazole IR 10mg + esomeprazole SR 10mg
干预措施: Nexium tab 20mg (Drug)
Nexium tab 20mg
Active Comparator
Esomeprazole magnesium trihydrate 22.3mg. Astrazeneca
干预措施: YYD601 20mg (Drug)
结局指标
主要结局
Cmax
时间窗: Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day
Cmax after single administration and repeated administration
AUC
时间窗: Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day
AUC after single administration and repeated administration
次要结局
- Tmax(pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day)
- AUC(pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day)
- t1/2(pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's DiseaseParkinson's DiseaseNCT06565195Prevail Therapeutics124
已完成
1 期
Single and Multiple Ascending Dose Study of JW1601 for Healthy VolunteersHealthyNCT04018170JW Pharmaceutical102
已完成
3 期
Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD PatientsNon-erosive Reflux DiseaseNCT03967886Yooyoung Pharmaceutical Co., Ltd.170
终止
2 期
Efficacy and Safety Study of SYR-619 in Treating Subjects With Type 2 Diabetes MellitusDiabetes MellitusNCT00763347Takeda82
已完成
3 期
A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal SurgeryVenous ThromboembolismNCT00942435Astellas Pharma Inc156