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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-19

No results posted yet for this study

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

Interventions

DRUG

DWJ1230

Daewoong Pharmaceutical

DRUG

DWB2001

Daewoong Bio

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05816681 on ClinicalTrials.gov