An Open-Label, Randomized, Fasting Condition, Single-dose, Cross-over Study to Evaluate the Bioequivalence "DA-5215 Tab" and "DA-5215-R Tab" in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Area Under the plasma Concentration versus time curve(AUCt)
研究概览
简要总结
An Open-Label, Randomized, Fasting Condition, Single-dose, Cross-over Study to Evaluate the Bioequivalence between "DA-5215 Tab" and "DA-5215-R Tab" in Healthy Volunteers
详细描述
- Study design: An open-Label, randomized, 2-sequence, 2-period, fasting condition, single-dose, per oral, cross-over study
- Administration method:
The subject should maintain a minimum of 10 hours of fasting status before administration, and give an oral dose of 1 tablet (DA-5215 or DA-5215-R) with 150 mL of water at around 8 a.m. on 1D of each period. The subject should not chew or break the drug, but should swallow in whole with water. The difference in administration time between the 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,15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 hours after the administration (total 16 times)
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
- •A person who aged 19 or older at the time of screening
- •BMI of 18 to 30 (BMI calculation: kg/m2)
- •Males weighing 50kg or more, Females weighing 45kg 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 agreed to use contraception from the first administration of IP to a week after the last administration of IP
- •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
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 8 weeks 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
- •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
RT
T: "DA-5215" R: "DA-5215-R"
干预措施: DA-5215 Tab (Drug)
RT
T: "DA-5215" R: "DA-5215-R"
干预措施: DA-5215-R Tab (Drug)
TR
T: "DA-5215" R: "DA-5215-R"
干预措施: DA-5215 Tab (Drug)
TR
T: "DA-5215" R: "DA-5215-R"
干预措施: DA-5215-R Tab (Drug)
结局指标
主要结局
Area Under the plasma Concentration versus time curve(AUCt)
时间窗: Pre-dose ~ 48hours
Area Under the plasma Concentration versus time curve(AUCt)
Peak Plasma Concentration(Cmax)
时间窗: Pre-dose ~ 48hours
Peak Plasma Concentration(Cmax)
次要结局
- Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)(Pre-dose ~ 48hours)
- Terminal phase of Half-life(t1/2)(Pre-dose ~ 48hours)
- Time of peak concentration(Tmax)(Pre-dose ~ 48hours)
- Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity(AUCt/AUC∞)(Pre-dose ~ 48hours)