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临床试验/NCT07590167
NCT07590167尚未招募1 期

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of AD-231 Compared to Coadministration of AD-231A, AD-231D and AD-231C in Healthy Adult Volunteers

Addpharma Inc.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
60
试验地点
1

研究概览

简要总结

A Study to Evaluate the Safety and Pharmacokinetics of AD-231 Compared to Coadministration of AD-231A, AD-231D and AD-231C

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 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
  • The Age equal to or greater than 19 and under 65 years in healthy volunteers at the time of screening visit

排除标准

  • Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
  • Other exclusions applied

研究组 & 干预措施

Sequence A (RT)

Experimental

Period 1: Reference Drug(AD-231A, AD-231D and AD-231C), Period 2 : Test Drug(AD-231)

干预措施: AD-231 (Drug)

Sequence A (RT)

Experimental

Period 1: Reference Drug(AD-231A, AD-231D and AD-231C), Period 2 : Test Drug(AD-231)

干预措施: AD-231A, AD-231D and AD-231C (Drug)

Sequence B (TR)

Experimental

Period 1: Test Drug(AD-231), Period 2 : Reference Drug(AD-231A, AD-231D and AD-231C)

干预措施: AD-231 (Drug)

Sequence B (TR)

Experimental

Period 1: Test Drug(AD-231), Period 2 : Reference Drug(AD-231A, AD-231D and AD-231C)

干预措施: AD-231A, AD-231D and AD-231C (Drug)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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