NCT05816681

Assessment of Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea.

An Open-label, Randomized, Multiple Dose, Parallel Study to Assess Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea(IBS-D)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess elemental impurities level after dministration of dioctahedral smectite in subjects with functional diarrhea or irritable bowel syndrome with predominant diarrhea. Male or female subjects aged between 19 and 60 years will participate in the study. The study design is an opne-label, randomized, multiple dose paraller study. The patients were randomly assigned to DWJ1230 or DWB2001. It is intended that a total of 60 subjects will be enrolled to ensure that at least 24 subjects will complete the study.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	DWJ1230	Daewoong Pharmaceutical
DRUG	DWB2001	Daewoong Bio

Timeline

• Start date: 2022-08-22
• Primary completion: 2023-02-06
• Completion: 2023-04-10
• First posted: 2023-04-18
• Last updated: 2023-04-19

Locations

1 site across 1 country: South Korea