A Randomized, Open-label, 3-way Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics and Safety of Single-dose Cavir Tab. 0.5mg With Baraclude Tab. 0.5mg in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 主要终点
- Peak plasma concentration (Cmax) of Entecavir.
研究概览
简要总结
In this clinical trial, the investigator will clarify the difference in pharmacokinetics between the group single dose Cavir Tab. 0.5mg and single dose Cavir Tab. 0.5mg with high fatty meal for healthy adult volunteer.
The investigators evaluate the effect of food intake on the absorption of Cavir Tab. 0.5mg.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male, aged 19 ~ 45 at screening date
- •Subject's weight is in range from -120 percentage to +120 percentage of ideal body weight which is calculated by { height (cm) - 100} * 0.
- •The Subject is willing and able to provide written informed consent to participate in the study
排除标准
- •Subject has a history of clinically significant disease.
- •Subject has a digestive disease (Crohn's disease, ulcer, acute or chronic pancreatitis etc) or abdomen surgery (exclude, simple appendectomy or hernia operation).
- •Subject has a hypersensitivity history which is clinically significance or additives.
- •Subject is inappropriate to screening (disease history, physical examination, vital sings, electrocardiogram, laboratory test etc.)
- •Subject has a laboratory test result as indicated by and one of the following.
- •serum aspartate aminotransferase> 1.25 * normal limit
- •serum Total bilirubin > 1.5 * normal upper limit
- •serum CPK > 1.5 * normal upper limit
- •eGFR(estimated Glomerular Filtration Rate) calaulated by MDRD (Modification of Diet in Renal Disease) formula < 60 mL/min/1.73m2
- •Subject is hypertension(SBP>140mmHg or DBP>90mmHg) or hypotension(SBP<90mmHg, DBP<60mmHg)
- •Subject has a drug abusing history.
- •Subject is currently abusing alcohol (more than 210 g/week), caffeine(more than 5cups/day) or smoking(more than half pack).
研究组 & 干预措施
Baraclude Tab. 0.5mg, fasting
Single dose Baraclude Tab. 0.5mg, fasting state
干预措施: Baraclude Tab. 0.5mg, fasting (Drug)
Cavir Tab. 0.5mg, fasting
Single dose Cavir Tab. 0.5mg, fasting state
干预措施: Cavir Tab. 0.5mg, fasting (Drug)
Cavir Tab. 0.5mg, high fatty meal
Single dose Cavir Tab. 0.5mg, high fatty meal
干预措施: Cavir Tab. 0.5mg, high fatty meal (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) of Entecavir.
时间窗: Within 6 Months After Final Visit of Subject
phamacokinetic parameter
Area under the plasma concentration versus time curve, last (AUClast) of entecavir.
时间窗: Within 6 Months After Final Visit of Subject.
phamacokinetic parameter
Number of participants with adverse events.
时间窗: Within 6 Months After Final Visit of Subject
次要结局
- Area under the plasma concentration versus time curve, infinite (AUCinf) of entecavir.(Within 6 Months After Final Visit of Subject.)
- The time at which the Cmax is observed (Tmax) of entecavir.(Within 6 Months After Final Visit of Subject.)
- Terminal half-life (T1/2) of entecavir.(Within 6 Months After Final Visit of Subject.)
研究者
Dong-seok Yim
Prof.
Seoul St. Mary's Hospital