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临床试验/NCT02783638
NCT02783638已完成1 期

A Open-label, Randomized, Crossover Clinical Trial to Assess the PK of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR and the Food Effect of High Fat Diet After Single Dosing in Healthy Male Volunteers

Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Cohort 2: Cmax

研究概览

简要总结

This study is to assess the pharmacokinetics of Pregabalin controlled release formulation after multiple dosing as compared to Pregabalin immediate release formulation and the food effect of high fat diet after single dosing in healthy male volunteers.

详细描述

Cohort 1 study is to assess the PK of Pregabalin controlled release formulation as compared to Pregabalin immediate release formulation. Cohort 1 subjects will be admitted to the clinic at Day 1. All subjects will receive multiple dosing for three days of YHD1119 or Pregabalin IR and will remain in the clinic until completion of all assessment on Day 19 including collection of PK sample. The treatment periods were separated by a washout period (10-17 days).

Cohort 2 study is to assess the food effect of high fat diet after single dosing. Cohort 2 subjects will be admitted to the clinic at Day -1. All subjects will receive a single dose of YHD1119 and will remain in the clinic until completion of all assessment on Day 9 including collection of PK sample. The treatment periods were separated by a washout period (7-14 days).

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 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy male with body mass index (BMI) between 18.5 and 28 kg/m2
  • Who has not suffered from clinically significant disease
  • Provision of signed written informed consent

排除标准

  • History of and clinically significant disease
  • A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
  • Administration of other investigational products within 3 months prior to the first dosing

研究组 & 干预措施

YHD1119 (Pregabalin 300mg)

Experimental

YHD1119 (Pregabalin 300mg)

干预措施: YHD1119 (Drug)

Lyrica (Pregabalin 150mg)

Active Comparator

Lyrica (Pregabalin 150mg)

干预措施: Lyrica (Drug)

结局指标

主要结局

Cohort 2: Cmax

时间窗: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours

Cohort 2: AUCtau

时间窗: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours

Cohort 1: AUCtau

时间窗: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours

Cohort 1: Cmax

时间窗: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours

次要结局

未报告次要终点

研究者

发起方
Yuhan Corporation
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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