NCT02336854已完成1 期
Tacrobell tab_Phase1_PK
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- AUClast
研究概览
简要总结
A randomized, open-label, two-way crossover study to assess the tolerability and pharmacokinetics of Tacrobell® Tab. and Prograf® Cap. after a single oral dose in healthy male volunteers.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Understand the requirements of the study and voluntarily consent to participate in the study.
- •Healthy male volunteer in the age between 20 and 45 years old.
- •Body weight ≥ 55 kg and 30.0kg/m2 ≥ BMI ≥ 18.0kg/m2
排除标准
- •presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
- •any chronic disease which might interfere with resorption, distribution, metabolism or excretion of the drug, or major surgery of the gastrointestinal tract except for appendectomy
- •any history of drug hypersensitivity (especially to the active and inactive ingredients of the tacrolimus preparation)
- •administration of cyclosporine or Bosentan
- •administration of potassium sparing diuretic
- •Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •SBP > 150 mmHg or< 90 mmHg
- •DBP > 100 mmHg or < 50 mmHg
- •positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies, RPR
- •AST or ALT > 1.5*ULN, e-GFR < 80 mL/min
- •history of drug abuse or positive drug screening test
- •intake or administration of any ethical or herbal medication medication within 2 weeks, intake or administration of any OTC or vitamin preparations
- •medication with metabolizing enzyme inducers or inhibitors such as barbitals within 1 month before first dosing
- •administration of another study medications within 3 months before first dosing
- •blood donation in 2 months, component blood donation within 1 month or blood transfusion before first dosing
- •Alcohol > 21 units/week or cannot stop drinking during the study
- •Cigarette > 10 cigarettes/day or cannot stop smoking during hospitalization
- •consumption of beverages or food containing caffeine(e.g.coffee, tea) during hospitalization
- •consumption of grapefruit or food containing grapefruit during hospitalization
- •Not eligible to participate for the study at the discretion of investigator.
研究组 & 干预措施
Tacrobell tab. 2mg
Experimental
2mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover)
干预措施: Tacrobell tab. 2mg (Drug)
Prograf cap. 2mg
Active Comparator
1mg/capsule, PO, 2 capsule once daily for Period I & II D1(crossover)
干预措施: Prograf cap. 2mg (Drug)
结局指标
主要结局
AUClast
时间窗: up to 96 hous postdose
Cmax
时间窗: up to 96 hous postdose
次要结局
- Tmax(up to 96 hous postdose)
- CL/F(up to 96 hous postdose)
- AUCinf(up to 96 hous postdose)
- t1/2(up to 96 hous postdose)
研究者
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