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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWJ1230 | Experimental |
| |
| DWB2001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWJ1230 | Drug | Daewoong Pharmaceutical |
| |
| DWB2001 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the concentration of lead in blood after administration of Investigational Product | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess blood concentration of other Class I(Cadmium, Arsenic, Mercury) after administration of Investigational Product | Day 7 | |
| To assess blood concentration of other Class IIa(Cobalt, Nickel) and of aluminium after administration of Investigational Product |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Seoul ST. Mary's Hospital. | Seoul | South Korea |
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| Drug |
Daewoong Bio |
|
| Day 7 |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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