drugset / Trial / 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.

NCT05816681 ↗

Phase 1 Completed 60 enrolled Daewoong Pharmaceutical Co. LTD.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-08-22
Primary completion
2023-02-06
Completion
2023-04-10

Drugs

EvaluationDrugModalityDoseRoute
Subject DWB2001 Unknown — —
Subject DWJ1230 Unknown — —

Indications