NCT06164834尚未招募1 期
A Randomized, Open-label, Three-period, Multiple Dosing Crossover Clinical Trial to Evaluate the Influence of Tegoprazan on the Pharmacodynamics of Clopidogrel in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in P2Y12 Reaction Unit (PRU) from baseline
研究概览
简要总结
This study aims to evaluate the effects of tegoprazan or esomeprazole administered in combination with clopidogrel on the pharmacodynamics/Pharmacokinetics of clopidogrel in healthy adults
详细描述
Evaluation Criteria:
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged ≥ 19 years and ≤ 50 years on the date of the written informed consent
- •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.
排除标准
- •Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease
- •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
研究组 & 干预措施
Clopidogrel 75 mg
Active Comparator
Oral administration of clopidogrel 75 mg tablet once daily for 7 days
干预措施: Clopidogrel 75 mg (Drug)
Clopidogrel 75 mg + Tegoprazan 25 mg
Experimental
Oral administration of clopidogrel 75 mg tablet and tegoprazan 25 mg tablet once daily for 7 days
干预措施: Clopidogrel 75 mg (Drug)
Clopidogrel 75 mg + Tegoprazan 25 mg
Experimental
Oral administration of clopidogrel 75 mg tablet and tegoprazan 25 mg tablet once daily for 7 days
干预措施: Tegoprazan 25 mg (Drug)
Clopidogrel 75 mg + Esomeprazole 20 mg
Experimental
Oral administration of clopidogrel 75 mg tablet and esomeprazole 20 mg tablet once daily for 7 days
干预措施: Clopidogrel 75 mg (Drug)
Clopidogrel 75 mg + Esomeprazole 20 mg
Experimental
Oral administration of clopidogrel 75 mg tablet and esomeprazole 20 mg tablet once daily for 7 days
干预措施: Esomeprazole 20mg (Drug)
结局指标
主要结局
Change in P2Y12 Reaction Unit (PRU) from baseline
时间窗: Pre-dose(0h) on days 1, 3, 5, 7 and 8 in each period
Pharmacodynamic blood sampling to measure PRU using VerifyNow® system
次要结局
未报告次要终点
研究者
研究点 (1)
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