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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.

Primary Purpose

Diarrhea

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWJ1230
DWB2001
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects with chronic functional Diarrhea. (included Irritable Bowel Syndrome with perdominant diarrhea(IBS-D)). Male or Female subjects aged between 19 and 60 years at screening. Body Mass Index(BMI) between 18 and 27kg/m2 in male, 17 and 26kg/m2 in female. ※ BMI (kg/m2) = body weight (kg)/[height (m)]2 Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information. Exclusion Criteria: No history or clinically significant symptoms or severe disease, including cardiac, neurological, pulmonary, hepatic, biliary, gastrointestinal, endocrinologic, or renal disorders, or cancer. Identified or strongly suspected organic cause to diarrhea. Celiac disease or Intestinal malabsorption, Unspecified intestinal malabsorption. History of any serious adverse reaction or adverse event or hypersensitivity to any component of investigational product. Constipation, Iron deficiency anaemia, Hypocalcaemia, Osteoporosis. Known domestic, leisure or professional exposure to elemental impurities. Women who are breastfeeding or are planning to become pregnant during the study. Positive pregnancy test at screening. Presence of clinically significant physical, laboratory, vital signs, or ECG findings. Blood lead level > 3.3 μg/dL(=33.0 μg/L) at screening. galactose intolerance, fructose intolerance, Lapp lactase deficiency, sucurase-isomaltase deficiency, glucose-galactose malabsorption. Receipt of any investigational agent or study drug within 4 weeks prior to screening. Patients with history of alcohol or drug abuse. Subjects who donated whole blood within 2 months, donated blood components within 1 month. Subjects who have participated and taken investigational drug within 1 month prior to study drug administration. Subjects who the investigator considers inappropriate for the study due to other reasons.

Sites / Locations

  • The Catholic University of Korea, Seoul ST. Mary's Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DWJ1230

DWB2001

Arm Description

Outcomes

Primary Outcome Measures

To assess the concentration of lead in blood after administration of Investigational Product

Secondary Outcome Measures

To assess blood concentration of other Class I(Cadmium, Arsenic, Mercury) after administration of Investigational Product
To assess blood concentration of other Class IIa(Cobalt, Nickel) and of aluminium after administration of Investigational Product

Full Information

First Posted
April 4, 2023
Last Updated
April 18, 2023
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05816681
Brief Title
Assessment of Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea.
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
February 6, 2023 (Actual)
Study Completion Date
April 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DWJ1230
Arm Type
Experimental
Arm Title
DWB2001
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DWJ1230
Intervention Description
Daewoong Pharmaceutical
Intervention Type
Drug
Intervention Name(s)
DWB2001
Intervention Description
Daewoong Bio
Primary Outcome Measure Information:
Title
To assess the concentration of lead in blood after administration of Investigational Product
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
To assess blood concentration of other Class I(Cadmium, Arsenic, Mercury) after administration of Investigational Product
Time Frame
Day 7
Title
To assess blood concentration of other Class IIa(Cobalt, Nickel) and of aluminium after administration of Investigational Product
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with chronic functional Diarrhea. (included Irritable Bowel Syndrome with perdominant diarrhea(IBS-D)). Male or Female subjects aged between 19 and 60 years at screening. Body Mass Index(BMI) between 18 and 27kg/m2 in male, 17 and 26kg/m2 in female. ※ BMI (kg/m2) = body weight (kg)/[height (m)]2 Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information. Exclusion Criteria: No history or clinically significant symptoms or severe disease, including cardiac, neurological, pulmonary, hepatic, biliary, gastrointestinal, endocrinologic, or renal disorders, or cancer. Identified or strongly suspected organic cause to diarrhea. Celiac disease or Intestinal malabsorption, Unspecified intestinal malabsorption. History of any serious adverse reaction or adverse event or hypersensitivity to any component of investigational product. Constipation, Iron deficiency anaemia, Hypocalcaemia, Osteoporosis. Known domestic, leisure or professional exposure to elemental impurities. Women who are breastfeeding or are planning to become pregnant during the study. Positive pregnancy test at screening. Presence of clinically significant physical, laboratory, vital signs, or ECG findings. Blood lead level > 3.3 μg/dL(=33.0 μg/L) at screening. galactose intolerance, fructose intolerance, Lapp lactase deficiency, sucurase-isomaltase deficiency, glucose-galactose malabsorption. Receipt of any investigational agent or study drug within 4 weeks prior to screening. Patients with history of alcohol or drug abuse. Subjects who donated whole blood within 2 months, donated blood components within 1 month. Subjects who have participated and taken investigational drug within 1 month prior to study drug administration. Subjects who the investigator considers inappropriate for the study due to other reasons.
Facility Information:
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital.
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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