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

• Status: Completed
• Trial end date: 2020-03-20
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yooyoung Pharmaceutical Co., Ltd.
• Treatments: Esomeprazole

Criteria

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.