GERD
Conditions
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.
Interventions
DRUGYYD601 20mg
Esomeprazole IR 10mg + Esomeprazole SR 10mg (Expected efficacy and effects: GERD)
DRUGNexium tab 20mg
Esomeprazole magnesium trihydrate 22.3mg Effecacy and Effects: GERD and Antibiotics combined therapy to eradicate the Helicobacter pylori
Sponsors
Yooyoung Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed