A Open-Label, Randomized, 6-sequence, 3-period, Fasting Condition, Singledose, Per Oral, Cross-over Study to Evaluate the Bioequivalence Between "DA-5209 60mg Tab" and "Lixiana 60mg Tab" in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Area Under the plasma Concetration versus time curve(AUCt) of Edoxaban
研究概览
简要总结
An Open-Label, Randomized, 6-sequence, 3-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "DA-5209 60mg Tab" and "Lixiana 60mg Tab" in Healthy Volunteers
详细描述
- Study design: An open-Label, randomized, 6-sequence, 3-period, fasting condition, single-dose, per oral, cross-over study
- Administration method:
The subject should maintain a minimum of 10 hours of empty stomach before administration, and give an oral dose of 1 tablets (DA-5209 60mg) without water or (DA-5209 60mg or Lixiana 60mg) with 150 mL of water at around 8 a.m. on the day of the test. The subject should not chew or break the drug, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the blood collection time. 3. Wash out period: at least 7 days 4. Blood collection time: Before the administration, 5, 10, 15, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hr after the administration (total 15 times) 5. Analysis: Measurement of the concentration of an unchangeable substance of Edoxaban in plasma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •A person who aged 19 or older at the time of screening
- •BMI of 18 to 30 (BMI calculation: kg/m2)
- •◦Males or Females weighing 60kg or more
- •No congenital or chronic diseases or pathological symptoms
- •A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
- •A person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature
- •A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP
排除标准
- •A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to the first administration of IP
- •A person who has participated in other clinical trials within six months prior to the first administration of the IP
- •A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before the first administration of IP
- •A person who has medical history of gastric resection that can affect the drug absorption
- •A person with a history of regular alcohol intake within a month prior to the first administration of the IP:
- •Male: More than 21 cups/week
- •Female: More than 14 cups/week (1 cup: 50 ml of soju, 250 ml of beer, 30ml of spirits)
- •A person who is hypersensitive to any of the IP components, with clinically significant bleeding, with end-stage renal disease and have kidney dialysis, with hepatic disease related to blood coagulation disorder and clinically significant risk of bleeding, with severe liver impairment, with an increased risk of bleeding, use combination therapy with other anticoagulants, Severe hypertension factor, have undergone artificial heart valve replacement
- •A person who has medical history of mental disease
- •A person who is judged not to be suitable for the study by the investigator
- •Lactating or possibly pregnant women
研究组 & 干预措施
T1T2R
Period I: T1, "DA-5209 60mg" without water Period II: T2, "DA-5209 60mg" with 150mL water Period III: R, "Lixiana 60mg" with 150mL water
干预措施: DA-5209 60mg Tab (Drug)
T1T2R
Period I: T1, "DA-5209 60mg" without water Period II: T2, "DA-5209 60mg" with 150mL water Period III: R, "Lixiana 60mg" with 150mL water
干预措施: Lixiana 60mg Tab (Drug)
T1RT2
Period I: T1, "DA-5209 60mg" without water Period II: R, "Lixiana 60mg" with 150mL water Period III: T2, "DA-5209 60mg" with 150mL water
干预措施: DA-5209 60mg Tab (Drug)
T1RT2
Period I: T1, "DA-5209 60mg" without water Period II: R, "Lixiana 60mg" with 150mL water Period III: T2, "DA-5209 60mg" with 150mL water
干预措施: Lixiana 60mg Tab (Drug)
RT1T2
Period I: R, "Lixiana 60mg" with 150mL water Period II: T1, "DA-5209 60mg" without water Period III: T2, "DA-5209 60mg" with 150mL water
干预措施: DA-5209 60mg Tab (Drug)
RT1T2
Period I: R, "Lixiana 60mg" with 150mL water Period II: T1, "DA-5209 60mg" without water Period III: T2, "DA-5209 60mg" with 150mL water
干预措施: Lixiana 60mg Tab (Drug)
RT2T1
Period I: R, "Lixiana 60mg" with 150mL water Period II: T2, "DA-5209 60mg" with 150mL water Period III: T1, "DA-5209 60mg" without water
干预措施: DA-5209 60mg Tab (Drug)
RT2T1
Period I: R, "Lixiana 60mg" with 150mL water Period II: T2, "DA-5209 60mg" with 150mL water Period III: T1, "DA-5209 60mg" without water
干预措施: Lixiana 60mg Tab (Drug)
T2RT1
Period I: T2, "DA-5209 60mg" with 150mL water Period II: R, "Lixiana 60mg" with 150mL water Period III: T1, "DA-5209 60mg" without water
干预措施: DA-5209 60mg Tab (Drug)
T2RT1
Period I: T2, "DA-5209 60mg" with 150mL water Period II: R, "Lixiana 60mg" with 150mL water Period III: T1, "DA-5209 60mg" without water
干预措施: Lixiana 60mg Tab (Drug)
T2T1R
Period I: T2, "DA-5209 60mg" with 150mL water Period II: T1, "DA-5209 60mg" without water Period III: R, "Lixiana 60mg" with 150mL water
干预措施: DA-5209 60mg Tab (Drug)
T2T1R
Period I: T2, "DA-5209 60mg" with 150mL water Period II: T1, "DA-5209 60mg" without water Period III: R, "Lixiana 60mg" with 150mL water
干预措施: Lixiana 60mg Tab (Drug)
结局指标
主要结局
Area Under the plasma Concetration versus time curve(AUCt) of Edoxaban
时间窗: Before administration ~ 48hours
Area Under the plasma Concetration versus time curve(AUCt) of Edoxaban
Peak Plasma Concentration(Cmax) of Edoxaban
时间窗: Before administration ~ 48hours
Peak Plasma Concentration(Cmax) of Edoxaban
次要结局
- Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) of Edoxban(Before administration ~ 48hours)
- Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity(AUCt/AUC∞) of Edoxaban(Before administration ~ 48hours)
- % of concentration compared to Maximum observed plasma concentration(Cmax) of Edoxaban(Before administration ~ 48hours)
- Time of peak concentration(Tmax) of Edoxaban(Before administration ~ 48hours)
- Terminal phase of Half-life(t1/2) of Edoxaban(Before administration ~ 48hours)
- Absorption rate constant(Ka) of Edoxaban(Before administration ~ 48hours)