临床试验/NCT05155072

NCT05155072已完成1 期

A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of DW1903, DW1903-R1 and DW1903-R2 in Healthy Adult Volunteers

Daewon Pharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 31 人开始时间: 2020年5月15日最近更新: 2021年12月13日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Daewon Pharmaceutical Co., Ltd.
入组人数: 31
试验地点: 1
主要终点: pH monitoring

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Randomized, Open-label, Oral in healthy male volunteers

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: Male
接受健康志愿者: 是

入选标准

•Healthy Volunteers who are ≥19 years old
•BMI between 18 and 30 kg/m2
•Body weight ≥50kg

排除标准

•Clinically significant Medical History

研究组 & 干预措施

Sequence E

Experimental

干预措施: DW1903 (Drug)

Sequence E

Experimental

干预措施: DW1903-R1 (Drug)

Sequence E

Experimental

干预措施: DW1903-R2 (Drug)

Sequence A

Experimental

干预措施: DW1903 (Drug)

Sequence A

Experimental

干预措施: DW1903-R1 (Drug)

Sequence A

Experimental

干预措施: DW1903-R2 (Drug)

Sequence B

Experimental

干预措施: DW1903 (Drug)

Sequence B

Experimental

干预措施: DW1903-R1 (Drug)

Sequence B

Experimental

干预措施: DW1903-R2 (Drug)

Sequence C

Experimental

干预措施: DW1903 (Drug)

Sequence C

Experimental

干预措施: DW1903-R1 (Drug)

Sequence C

Experimental

干预措施: DW1903-R2 (Drug)

Sequence D

Experimental

干预措施: DW1903 (Drug)

Sequence D

Experimental

干预措施: DW1903-R1 (Drug)

Sequence D

Experimental

干预措施: DW1903-R2 (Drug)

Sequence F

Experimental

干预措施: DW1903 (Drug)

Sequence F

Experimental

干预措施: DW1903-R1 (Drug)

Sequence F

Experimental

干预措施: DW1903-R2 (Drug)

结局指标

主要结局

pH monitoring

时间窗: up to day 5

Pharmacodynamic Endpoint

次要结局

未报告次要终点

研究者

发起方

Daewon Pharmaceutical Co., Ltd.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

Loading locations...

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