Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)

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)

Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)

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.

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.