NCT04867200Unknown1 期
An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-344 in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUCt(Area Under Curve last) of CKD-344
研究概览
简要总结
A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-344
详细描述
A Phase 1 Clinical Trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of CKD-344.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged ≥ 19 years
- •Weight ≥60kg, with calculated body mass index(BMI) of 18 to 30 kg/m2
- •Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
- •Those who are eligible for clinical trials based on laboratory (hematology, blood coagulation, blood chemistry, serology, urinalysis) at screening.
- •Those who agree to contraception during the participation of clinical trial.
- •Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
排除标准
- •Those who has a medical evidence or a history of clinically significant gastrointestinal, cardiovascular, endocrine, pulmonary, hematological, infective disease, renal, urinary, psychiatric, neurologic, skeletomuscular, immune, etc.
- •Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
- •Those who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product.
- •Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- •Those who donated whole blood within 8 weeks or blood components within 4 weeks prior to the first dose of the investigational product.
- •Those who exceed an alcohol and cigarette consumption than below criteria. A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week B. Smoking: 20 cigarettes/day
- •Those who exceeds 2 times the upper limit of the reference range of AST(or ALT) or 1.5 times the upper limit of the reference range of γ-GTP.
- •Those who have hypersensitivity to the drug or the drug ingredient, such as anaphylactic reactions.
- •Those who have specific disease(e.g. severe bleeding disorder, severe renal/hepatic disease, uncontrolled severe hypertension, etc.)
- •Those who were deemed inappropriate to participate in the study by the investigator.
- •Those who have a pregnant or nursing woman.
研究组 & 干预措施
Group B
Experimental
- Period 1: Test drug(CKD-344 60 mg)
- Period 2: Reference drug(Lixiana 60 mg)
干预措施: CKD-344 (Drug)
Group A
Experimental
- Period 1: Reference drug(Lixiana 60 mg)
- Period 2: Test drug(CKD-344 60 mg)
干预措施: Lixiana(D006) (Drug)
Group A
Experimental
- Period 1: Reference drug(Lixiana 60 mg)
- Period 2: Test drug(CKD-344 60 mg)
干预措施: CKD-344 (Drug)
Group B
Experimental
- Period 1: Test drug(CKD-344 60 mg)
- Period 2: Reference drug(Lixiana 60 mg)
干预措施: Lixiana(D006) (Drug)
结局指标
主要结局
AUCt(Area Under Curve last) of CKD-344
时间窗: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Area under the plasma concentration time curve of CKD-344, from time zero up to the last measurable concentration.
Cmax
时间窗: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
The maximum concentration observed of CKD-344 over blood sampling time.
次要结局
未报告次要终点
研究者
研究点 (1)
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