A Open-Label, Randomized, 2-sequence, 4-period, Fasting Condition, Singledose, Per Oral, Cross-over Study to Evaluate the Bioequivalence Between "Dong-A Atorvastatin 80mg Tab" and "Lipitor 80mg Tab" in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Area Under the plasma Concetration versus time curve(AUCt) of Atorvastatin
研究概览
简要总结
An Open-Label, Randomized, 2-sequence, 4-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "Dong-A Atorvastatin 80mg Tab" and "Lipitor 80mg Tab" in Healthy Volunteers
详细描述
- Study design: An open-Label, randomized, 2-sequence, 4-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 (Dong-A Atorvastatin 80mg or Lipitor 80mg) 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, 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 3, 4, 6, 8, 12, 24, 36 hr after the administration (total 16 times) 5. Analysis: Measurement of the concentration of an unchangeable substance of Atorvastatin 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 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 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, taking glecaprevir, pibrentasvir, has active hepatic disease, Blood AST (GOT) or ALT (GPT) levels exceed the upper reference range limit by 3 times, muscle disease, or any genetic symtoms such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •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
RTRT
R: "Lipitor 80mg Tab" T: "Dong-A Atorvastatin 80mg Tab"
干预措施: Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab (Drug)
TRTR
R: "Lipitor 80mg Tab" T: "Dong-A Atorvastatin 80mg Tab"
干预措施: Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab (Drug)
结局指标
主要结局
Area Under the plasma Concetration versus time curve(AUCt) of Atorvastatin
时间窗: Before administration ~ 36hrs
Area Under the plasma Concetration versus time curve(AUCt) of Atorvastatin
Peak Plasma Concentration(Cmax) of Atorvastatin
时间窗: Before administration ~ 36hrs
Peak Plasma Concentration(Cmax) of Atorvastatin
次要结局
未报告次要终点