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Completed

NCT Number: NCT03985319

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook national university hospital

Daegu, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

YYD601 20mg

Drug

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

Other names: Experimental drug

Nexium tab 20mg

Drug

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

Other names: comparator drug

Primary outcomes

  1. Cmax

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

    Cmax after single administration and repeated administration

  2. AUC

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

    AUC after single administration and repeated administration

Secondary outcomes

  1. AUC

    Time frame: 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

    AUC after single administration and repeated administration

  2. Tmax

    Time frame: 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 after single administration and repeated administration

  3. t1/2

    Time frame: 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 after single administration and repeated administration

Sponsors and collaborators

Lead sponsor

Yooyoung Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 13, 2019
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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