An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Tacrobell Capsule 1mg Versus Prograf Capsule 1mg in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and prograf capsule 1mg.
详细描述
This will be an open label, randomized, single dose, 2-treatment, 2-period crossover study in healthy volunteers.Study treatments will be administered under fasting conditions.
Blood samples for the analysis of tacrolimus in blood will be obtained as follows: Predose(immediately prior to dosing), and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed the informed consent from prior to screening test
- •Between 19 years and 55 years in healthy male subject
- •Have not any congenital or chronic disease and medical symptoms
- •Body mass index(BMI) of 18 to 30 and a total body weight ≥ 55kg
- •Appropriate subject for the study judging from investigator
排除标准
- •Evidence or history of clinically significant hepatic, renal, neurologic, immune system, respiratory system, endocrine
- •Any condition possibly affecting drug absorption (e.g. gastrectomy)
- •Subject with hypersensitivity to tacrolimus or any excipient
- •Administration of cyclosporin or bosentan
- •Administration of potassium-sparing diuretics
- •Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •SBP<90 mmHg or DBP<50 mmHg, SBP>150 mmHg or DBP>100 mmHg at least 3 minutes of rest
- •A positive HBsAg, HCV Ab, HIV Ab, RPR
- •AST, ALT > 1.5*upper limit of normal range at the screening test
- •Subject with a history of drug abuse or a positive reaction for drug abuse at the screening test
- •Taking ETC medicine including oriental medicine within 14days before the first hospitalization or taking OTC medicine, vitamin within 7days
- •Use of any drugs known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initiation test
- •Participating in a bioequivalence study or other clinical study within 3 month preceding the first hospitalization
- •Blood donation or more within 2 month or component blood donation within 1 month prior to the first hospitalization
- •Continued to be drinking(alcohol> 21 units/week, 1 unit=10g of pure alcohol) or during clinical trials can not be drunk
- •Severe heavy smoker(cigarette> 10 cigarettes/day) during 3 months or can not be smoking during the clinical study
- •Continued to be taking caffeine or can not be taken caffeine
- •Continued to be taking grapefruit or can not be taken grapefruit
- •Not use of contraception during the clinical study
- •An impossible one who participates in the clinical trial by investigator's decision including for reason of laboratory test result
研究组 & 干预措施
Tacrobell capsule 1mg
Tacrolimus 1mg / 1 capsule
干预措施: Tacrobell capsule 1mg (Drug)
Prograf capsule 1mg
Tacrolimus 1mg / 1 capsule
干预措施: Prograf capsule 1mg (Drug)
结局指标
主要结局
AUClast
时间窗: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdese
AUClast: Area under the blood concentration-time profile from time zero to the time of the last quantifiable concentration
Cmax
时间窗: At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdese
Cmax: Maximum blood concentration
次要结局
- CL/F(At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose)
- T1/2(At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose)
- AUCinf(At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose)
- Tmax(At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose)