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

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ClinicalTrials.gov Identifier: NCT03985319
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Yooyoung Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
GERD Drug: YYD601 20mg Drug: Nexium tab 20mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : June 10, 2019
Estimated Primary Completion Date : July 10, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: YYD601 20mg
Esomeprazole IR 10mg + esomeprazole SR 10mg
Drug: Nexium tab 20mg
Esomeprazole magnesium trihydrate 22.3mg Effecacy and Effects: GERD and Antibiotics combined therapy to eradicate the Helicobacter pylori

Active Comparator: Nexium tab 20mg
Esomeprazole magnesium trihydrate 22.3mg. Astrazeneca
Drug: YYD601 20mg
Esomeprazole IR 10mg + Esomeprazole SR 10mg (Expected efficacy and effects: GERD)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985319


Contacts
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Contact: Min-Kyung Kwon +82-6202-7121 monica.kim@yypharm.co.kr
Contact: Ye Rum Kim +82-6202-7121 monica.kim@yypharm.co.kr

Sponsors and Collaborators
Yooyoung Pharmaceutical Co., Ltd.

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Responsible Party: Yooyoung Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03985319     History of Changes
Other Study ID Numbers: YYPCT_YYD601_P1(2)
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action