Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects
NCT ID: NCT06164834
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2023-12-05
2024-11-30
Brief Summary
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Detailed Description
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* Primary outcome Pharmacodynamic assessments using P2Y12 assay
* Secondary outcome Pharmacokinetics assessments on Cmax,ss, Cmin,ss, Cavg,ss, AUCτ,ss, Tmax,ss, t1/2,ss, CLss/F, Vd,ss/F, and PTF of clopidogrel
* Safety assessments with adverse event monitoring including subjective/ objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Clopidogrel 75 mg
Oral administration of clopidogrel 75 mg tablet once daily for 7 days
Clopidogrel 75 mg
Clopidogrel 75 mg tablet
Clopidogrel 75 mg + Tegoprazan 25 mg
Oral administration of clopidogrel 75 mg tablet and tegoprazan 25 mg tablet once daily for 7 days
Clopidogrel 75 mg
Clopidogrel 75 mg tablet
Tegoprazan 25 mg
Tegoprazan 25 mg tablet
Clopidogrel 75 mg + Esomeprazole 20 mg
Oral administration of clopidogrel 75 mg tablet and esomeprazole 20 mg tablet once daily for 7 days
Clopidogrel 75 mg
Clopidogrel 75 mg tablet
Esomeprazole 20mg
Esomeprazole 20 mg tablet
Interventions
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Clopidogrel 75 mg
Clopidogrel 75 mg tablet
Tegoprazan 25 mg
Tegoprazan 25 mg tablet
Esomeprazole 20mg
Esomeprazole 20 mg tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening
* Is given a detailed explanation and fully understood the study, then voluntarily decided to participate and provided written informed consent before any screening procedure
* Negative for serum Helicobacter pylori antibodies
* Judged by the investigator to be eligible for this study based on physical examination, laboratory test, inquiry, etc.
Exclusion Criteria
* Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease
* Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
* Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
* Blood total bilirubin, AST (GOT), and ALT (GPT) \> 1.5 x upper limit of normal range at the screening test
* Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10% at the screening test
* Systolic blood pressure is \< 90 mmHg or \> 139 mmHg, diastolic blood pressure \< 50 mmHg or \> 89 mmHg, or pulse rate is \< 45 beats/minute or \> 100 beats/minute when vital signs are measured in sitting position after resting for at least 3 minutes at the screening test
* Showing the following findings on ECG at the screening test: QTc \> 450 msec, PR interval \> 210 msec, QRS interval \> 120 msec, Other clinically significant findings
* P2Y12 Reaction Unit (PRU) outside the upper/lower limit of normal range by 10% as a result of P2Y12 assay at the screening test
* History of drug abuse or positive urine screening for drug abuse
* Considered ineligible to participate in the study by the investigator based on laboratory test results or other reasons
19 Years
50 Years
ALL
Yes
Sponsors
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HK inno.N Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Seung Hwan Lee
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital, Dept. of Clinical Pharmacology
Locations
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Seoul National University Hospital, Clinical Trial Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Seung Hwan Lee, MD, PhD
Role: primary
Other Identifiers
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IN_APA_123
Identifier Type: -
Identifier Source: org_study_id