A Randomized, Open-label, Single-dose, 2x2 Crossover Study to Compare the Safety/Tolerability and Pharmacokinetics Between and DA-2803 and Vemlidy® After Meal in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Cmax of DA-2803, Vemlidy
研究概览
简要总结
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of DA-2803 in healthy subjects
详细描述
To healthy subjects of ninety-six (96), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.
Reference drug: Vemlidy Tab. / Test drug: DA-2803 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.
- •Calculated body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2
- •BMI = Weight(kg)/ Height(m)2
- •Individuals who agreed proper contraception during the study and did consent to not donation of sperm and ovum before the termination of study
- •Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial
排除标准
- •History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
- •Any medical history that may affect drug absorption, distribution, metabolism and excretion.
- •Individuals who had history of hypersensitivity to Investigational drugs, derivative drugs or others drugs(aspirin and antibiotics etc.)
- •Any clinically significant chronic medical illness.
- •Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •Individuals with one of the following laboratory test results in screening.
- •AST, ALT > UNL (upper normal limit) x 1.5
- •Creatinine clearance ≤ 60 mL/min
- •Positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
- •Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration and use of over-the-counter medications within 10 days prior to study drug administration.
- •Individuals who cannot eat standard meal provided from clinical trial center.
- •Donation of blood within 60 days prior to study drug administration or apheresis within 30 days prior to the first IP administration.
- •Individuals who had received a blood transfusion within 60 days prior to study drug administration.
- •Exposure to any investigational drug within 6 months prior to the first IP administration.
- •Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
- •Individuals who had drinking (alcohol > 21unit/week) within 14 days prior to screening.
- •Heavy smoking (more than 10 cigarettes/day) within 14 days prior to screening.
- •Subjects having been deemed inappropriate for the trial as determined by the investigator.
研究组 & 干预措施
Reference-Test
干预措施: Vemlidy Tab (Drug)
Reference-Test
干预措施: DA-2803 Tab (Drug)
Test-Reference
干预措施: Vemlidy Tab (Drug)
Test-Reference
干预措施: DA-2803 Tab (Drug)
结局指标
主要结局
Cmax of DA-2803, Vemlidy
时间窗: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour
The maximum DA-2803/Vemlidy concentration in blood sampling time t
AUCt of DA-2803, Vemlidy
时间窗: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour
Area under the DA-2803/Vemlidy concentration in blood-time curve from zero to final
次要结局
未报告次要终点