跳至主要内容
临床试验/NCT07260851
NCT07260851招募中1 期

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "DWJ1622" and Co-administration of "DWC202313" and "DWC202314" in Healthy Volunteers

Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月5日最近更新:
干预措施

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Cmax

研究概览

简要总结

This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fasting conditions.

详细描述

This is an open-label, randomized, oral, single-dose, 2-sequence, 2-period, crossover Phase 1 study designed to compare the pharmacokinetics and safety profiles of DWJ1622 with the co-administration of DWC202313 and DWC202314 in healthy volunteers under fasting conditions. Subjects will be randomized to receive either DWJ1622 or the co-administration of DWC202313 and DWC202314 in different sequences across two study periods with an appropriate washout period.

The primary pharmacokinetic endpoints include the maximum observed plasma concentration (Cmax) and the area under the plasma concentration-time curve to the last measurable concentration (AUClast) of each study drug. Secondary endpoints include the area under the plasma concentration-time curve extrapolated to infinity (AUCinf), the ratio of AUClast to AUCinf (AUClast/AUCinf), the time to reach maximum plasma concentration (Tmax), and the terminal elimination half-life (t1/2). Safety will be evaluated based on adverse events and clinical laboratory tests.

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

DWJ1622

Experimental

干预措施: DWJ1622 (Drug)

DWJ1622

Experimental

干预措施: DWC202313, DWC202314 (Drug)

DWC202313, DWC202314

Experimental

干预措施: DWJ1622 (Drug)

DWC202313, DWC202314

Experimental

干预措施: DWC202313, DWC202314 (Drug)

结局指标

主要结局

Cmax

时间窗: At pre-dose (0 hours), and post-dose 1 to 72 hours.

Cmax of DWJ1622 and DWC202313, DWC202314

AUClast

时间窗: At pre-dose (0 hours), and post-dose 1 to 72 hours.

AUClast of DWJ1622 and DWC202313, DWC202314

次要结局

  • AUCinf(At pre-dose (0 hours), and post-dose 1 to 72 hours.)
  • AUClast/AUCinf(At pre-dose (0 hours), and post-dose 1 to 72 hours.)

研究者

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

研究点 (1)

Loading locations...

相似试验

Bioequivalence Study for the Safety and the... | 临床试验