An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of HL-TOF Tab. 5 mg Compared With Those of XelJanz Tab. in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
To evaluate the safety and pharmacokinetics of HL-TOF tab. 5 mg compared with those of XelJanz tab. in healthy volunteers
详细描述
The purpose of this study is to evaluate the safety and pharmacokinetics of tofacitinib after single oral administration of Xeljanz tab. 5mg as reference drug and HL-TOF tab. 5mg as test drug in healthy voluteers. AUC and Cmax would be evaluated for the pharmacokinetics. Adverse event, Laboratory examination and other examination result would be evaluated for the safety.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Years 19-60
- •No pathological symptoms or findings
- •Suitable for the criteria for examination
- •90≤SBP≤139, 60≤DBP≤89
- •Body weight≥50kg (Female≥45kg) and 18≤BMI≤30kg/m2
- •Contraceptive during the study period
- •Volunteer for the study and sign to ICF
排除标准
- •Subject with medical history which affect on the absorption of drug
- •Following condition: Mental illness, Hepatic disorder, Tuberculosis, ANC< 500cells/mm3, ALC<500cells/mm3, Hb<8g/dL
- •Subject with hypersensitivity reaction to HL-TOF and Xeljanz
- •Subject with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Subject who take a vaccination within 30 days
- •Subject who take a medication such as barbiturates within 30 days
- •Subject who take a medication that affect to the pharmacokinetics of drug within 10 days
- •Subject who take alcohol more than 21 cups per week
- •Subject who smoke 20 cigarettes per day
- •Subject who participate in any clinical investigation within 6 month prior to study medication dosing
- •Subject with whole blood donation within 60 days, component blood donation within 14 days, blood donation within 30 days
- •Subject with decision of non-participation through investigator's review
研究组 & 干预措施
Xeljanz tab. 5mg
Tofacitinib citrate (5mg as tofacitinib)
干预措施: Xeljanz tab. 5mg (Drug)
HL-TOF tab. 5mg
Tofacitinib freebase
干预措施: HL-TOF tab. 5mg (Drug)
结局指标
主要结局
Cmax
时间窗: 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour
Maximum concentration
AUC
时间窗: 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour
Area under curve
次要结局
- AE(0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour)