Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)
- Registration Number
- NCT03985319
- Lead Sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Brief Summary
Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description YYD601 20mg Nexium tab 20mg Esomeprazole IR 10mg + esomeprazole SR 10mg Nexium tab 20mg YYD601 20mg Esomeprazole magnesium trihydrate 22.3mg. Astrazeneca
- Primary Outcome Measures
Name Time Method Cmax Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day Cmax after single administration and repeated administration
AUC Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day AUC after single administration and repeated administration
- Secondary Outcome Measures
Name Time Method 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 AUC after single administration and repeated administration
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 Tmax after single administration and repeated administration
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 t1/2 after single administration and repeated administration
Trial Locations
- Locations (1)
Kyungpook national university hospital
🇰🇷Daegu, Korea, Republic of