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

NCT ID: NCT03985319

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2020-03-20

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.

Conditions

GERD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

YYD601 20mg

Esomeprazole IR 10mg + esomeprazole SR 10mg

Group Type: EXPERIMENTAL

Nexium tab 20mg

Intervention Type: DRUG

Esomeprazole magnesium trihydrate 22.3mg Effecacy and Effects: GERD and Antibiotics combined therapy to eradicate the Helicobacter pylori

Nexium tab 20mg

Esomeprazole magnesium trihydrate 22.3mg. Astrazeneca

Group Type: ACTIVE_COMPARATOR

YYD601 20mg

Intervention Type: DRUG

Esomeprazole IR 10mg + Esomeprazole SR 10mg (Expected efficacy and effects: GERD)

Interventions

YYD601 20mg

Esomeprazole IR 10mg + Esomeprazole SR 10mg (Expected efficacy and effects: GERD)

Intervention Type: DRUG

Nexium tab 20mg

Esomeprazole magnesium trihydrate 22.3mg Effecacy and Effects: GERD and Antibiotics combined therapy to eradicate the Helicobacter pylori

Intervention Type: DRUG

Other Intervention Names

Experimental drug; comparator drug

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yooyoung Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kyungpook national university hospital

Daegu, , South Korea

Countries

South Korea

References

Lee HW, Kang WY, Park JS, Lee JH, Park JJ, Gwon MR, Yoon YR, Seong SJ. A Pharmacokinetic/Pharmacodynamic Study of Esomeprazole Comparing a Dual Delayed-Release Formulation (YYD601) to a Conventional Formulation Following Multiple Administrations in Healthy Adult Subjects. Drug Des Devel Ther. 2025 Jan 8;19:97-110. doi: 10.2147/DDDT.S500253. eCollection 2025.

Reference Type: DERIVED

PMID: 39803609 (View on PubMed)

Other Identifiers

YYPCT_YYD601_P1(2)

Identifier Type: -

Identifier Source: org_study_id