NCT03261427已完成1 期
A Randomized, Open-label, Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration in Healthy Adult Volunteers: Part I- Single Dosing/Part II- Multiple Dosing
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
- 17
- 试验地点
- 1
- 主要终点
- Part I : AUClast of Pregabalin
研究概览
简要总结
The purpose of this trial to compare the pharmacokinetic characteristics of YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2, Vd/f, CL/f.
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
- All
- 接受健康志愿者
- 是
入选标准
- •19 years to 55 years healthy volunteers adult at screening visit
- •For male, weight is more than 55 kg, for female, weight is more than 50 kg.
- •Body mass index(BMI) value : 18.5 to 25.0 kg/m2
- •If female, should be included one at least as following
- •menopausal(menstruation for 2 years minimum)
- •surgery infertility
排除标准
- •Any history of drug overdose or dependence
- •Female who is pregnant or nursing
- •AST, ALT > ULN*1.25
- •Total bilirubin > ULN*1.5
- •CPK > ULN*1.5
研究组 & 干预措施
Lyrica Capsule(Pregabalin 150mg)
Active Comparator
Lyrica Capsule(Pregabalin 150mg), BID
干预措施: Lyrica 150Mg Capsule (Drug)
YNP-1807 Tablet(Pregabalin 330mg)
Experimental
YNP-1807(Pregabalin 330mg), QD
干预措施: YNP-1807 330Mg Tablet (Drug)
结局指标
主要结局
Part I : AUClast of Pregabalin
时间窗: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part II : Cmax,ss of Pregabalin
时间窗: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part I : Cmax of Pregabalin
时间窗: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Part II : AUCτ,ss of Pregabalin
时间窗: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
次要结局
- Part II : t1/2 of Pregabalin(Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
- Part I : Vd/F of Pregabalin(0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
- Part I : t1/2 of Pregabalin(0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
- Part I : CL/F of Pregabalin(0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
- Part I : AUCinf of Pregabalin(0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
- Part II : Cmin,ss of Pregabalin(Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
- Part I : Tmax of Pregabalin(0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
- Part II : Tmax,ss of Pregabalin(Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
- Part II : AUClast,ss of Pregabalin(Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
- Part II : CLss/F of Pregabalin(Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
- Part II : Vdss/F of Pregabalin(Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
- Part II : accumulation ratio(Cmax) of Pregabalin(Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
- Part II : accumulation ratio(AUCτ) of Pregabalin(Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours)
研究者
研究点 (1)
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