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临床试验/NCT06592495
NCT06592495尚未招募1 期

Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions

Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 52 人开始时间: 2024年10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
尚未招募
发起方
入组人数
52
主要终点
The maximum serum concentration(Cmax) of DWJ1589 and DWC202315

研究概览

简要总结

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.

详细描述

The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 19 year old
  • Healthy adult volunteers

排除标准

  • with a history of mental disorder
  • For female volunteers, those who are suspected of being pregnant or lactating

研究组 & 干预措施

Sequence A: RTRT

Experimental

T: DWJ1589 R: DWC202315

干预措施: Period 4 (Drug)

Sequence B: TRTR

Experimental

T: DWJ1589 R: DWC202315

干预措施: Period 1 (Drug)

Sequence B: TRTR

Experimental

T: DWJ1589 R: DWC202315

干预措施: Period 2 (Drug)

Sequence B: TRTR

Experimental

T: DWJ1589 R: DWC202315

干预措施: Period 3 (Drug)

Sequence B: TRTR

Experimental

T: DWJ1589 R: DWC202315

干预措施: Period 4 (Drug)

Sequence A: RTRT

Experimental

T: DWJ1589 R: DWC202315

干预措施: Period 2 (Drug)

Sequence A: RTRT

Experimental

T: DWJ1589 R: DWC202315

干预措施: Period 3 (Drug)

Sequence A: RTRT

Experimental

T: DWJ1589 R: DWC202315

干预措施: Period 1 (Drug)

结局指标

主要结局

The maximum serum concentration(Cmax) of DWJ1589 and DWC202315

时间窗: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.

Cmax of DWJ1589 and DWC202315

The Area under the curve(AUC)last of DWJ1589 and DWC202315

时间窗: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.

AUClast of DWJ1589 and DWC202315

次要结局

未报告次要终点

研究者

发起方
Daewoong Pharmaceutical Co. LTD.
申办方类型
Industry
责任方
Sponsor

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