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

GERD Clinical Trial

Official title:

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 Details — Status: Completed

Administrative data

• NCT number: NCT03985319
• Other study ID #: YYPCT_YYD601_P1(2)
• Status: Completed
• Phase: Phase 1
• Start date: July 8, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: May 2021
• Source: Yooyoung Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 20, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• GERD

Intervention

Drug:
• YYD601 20mg
Esomeprazole IR 10mg + Esomeprazole SR 10mg (Expected efficacy and effects: GERD)
• Nexium tab 20mg
Esomeprazole magnesium trihydrate 22.3mg Effecacy and Effects: GERD and Antibiotics combined therapy to eradicate the Helicobacter pylori

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook national university hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yooyoung Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Cmax after single administration and repeated administration	Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day
Primary	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	AUC	AUC after single administration and repeated administration	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
Secondary	Tmax	Tmax after single administration and repeated administration	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
Secondary	t1/2	t1/2 after single administration and repeated administration	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