Clinical trial NCT03985319: Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: GERD
Lead sponsor: Yooyoung Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-13
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cmax
timeFrame: Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day
measure: AUC
timeFrame: Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day
Secondary outcomes:
measure: AUC
timeFrame: 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
measure: Tmax
timeFrame: 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
measure: t1/2
timeFrame: 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
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
Study officials:
References: