NCT06165237已完成1 期
A Phase I Clinical Trial to Evaluate the Drug-drug Interaction and Safety Between "BR6001-1" and "BR6001-2" in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cmax,ss
研究概览
简要总结
The purpose of this clinical trial is to evaluate the drug-drug interaction and safety between "BR6001-1" and "BR6001-2" in healthy adult volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit.
- •Those who sign written consent spontaneously to follow the study directions after listening to and understanding sufficient explanation of this clinical trial.
排除标准
- •Those who have a medical history of gastrointestinal diseases(Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (Except for simple appendectomy, hernia surgery) that may affect the absorption of investigational products.
- •Those who have hypersensitivity reaction to investigational products or their additives in addition to other painkillers, anti-inflammatory drugs, antirheumatic drugs, benzimidazole.
- •Those who have a history of clinically significant hypersensitivity reaction.
- •Those taking anticoagulants, atazanavir, Rilpivirine and methotrexate.
- •Those who eat an abnormal food that may affect the absorption, distribution, metabolism and excretion of investigational products or who eat food that may affect drug metabolism.
- •Those who take any prescription drugs(including herbal medicines) that may affect characteristics of investigational product within 14 days prior to the date of first administration or who take any over-the-counter (OTC) drugs or vitamins within 10 days prior to the date of first administration (however, if it don't affect subject's safety and study's result according to the judgment of the investigator, they may participate in the study.)
- •Those who take inducer and inhibitor of drug metabolizing enzymes such as barbiturates, etc. within 1 month prior to the first administration
研究组 & 干预措施
BR6001-1+BR6001-2
Experimental
干预措施: BR6001-1 (Drug)
BR6001-1+BR6001-2
Experimental
干预措施: BR6001-2 (Drug)
结局指标
主要结局
Cmax,ss
时间窗: 0~24 hours after administration
Maximum Concentration of Drug in Plasma at Steady State
The change(%) of Aspirin Reaction Units(ARU) & Thromboxane B2 (TxB2) at 24h after repeated administration (last administration date) compared to baseline (first administration date)
时间窗: 0, 6, 24 hours after administration
AUCτ,ss
时间窗: 0~24 hours after administration
Area under the Plasma Concentration-Time Curve During Dosing Interval (tau) at Steady State
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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