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

NCT03985319 | Completed Phase 1

• 1 other identifier: YYPCT_YYD601_P1(2)
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

GERD

Outcome Measures

Primary Outcomes (2)

• Cmax

  Cmax after single administration and repeated administration

  Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day

• AUC

  AUC after single administration and repeated administration

  Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

YYD601 20mg

EXPERIMENTAL

Esomeprazole IR 10mg + esomeprazole SR 10mg

Drug: Nexium tab 20mg

Nexium tab 20mg

ACTIVE COMPARATOR

Esomeprazole magnesium trihydrate 22.3mg. Astrazeneca

Drug: YYD601 20mg

Interventions

YYD601 20mg DRUG

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

Also known as: Experimental drug

Nexium tab 20mg

Nexium tab 20mg DRUG

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

Also known as: comparator drug

YYD601 20mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yooyoung Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Kyungpook national university hospital

Daegu, South Korea

Location

Related Publications (1)

• 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.

  PMID: 39803609 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Drugs, Investigational; Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 13, 2019
• Study Start: July 8, 2019
• Primary Completion: February 7, 2020
• Study Completion: March 20, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

KR (1)