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Japanese male healthy volunteers will receive NPF-08. The efficacy of NPF-08 will be assessed by intestinal cleaning degree. The safety of NPF-08 will be evaluated based on adverse events and adverse drug reactions observed from the date of administration to 7 days after administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPF-08 Low dose (1-day treatment) | Experimental |
| |
| NPF-08 Medium dose (2-day split dose) | Experimental |
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| NPF-08 High dose (2-day split dose) | Experimental |
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| NPF-08 Medium dose (1-day treatment) | Experimental |
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| NPF-08 High dose (1-day treatment) | Experimental |
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| NPF-08 Low~High dose (1-day treatment) | Experimental |
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| NPF-08 Medium~High dose (2-day split dose) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPF-08 | Drug | Drug: NPF-08 Arms: NPF-08 oral sulfate solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Effective rate of overall intestinal cleaning effect (after washing of the observed region) by the Endoscopic Image Evaluation Committee (EIEC) | 1day |
| Measure | Description | Time Frame |
|---|---|---|
| Effective rate of overall intestinal cleaning effect (before washing of observed site) by EIEC | 1day | |
| Cleaning effect by intestinal site (before/after washing of observed site) | 1day | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Osaka | Japan |
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| Degree of bubbles by intestinal site |
| 1day |
| Time for completion of the bowel cleaning | 1day or 2day |
| Total dose of the investigational drug | 1day |
| Acceptability by subjects | up to 6hr |
| Coincidence rate of intestinal cleansing degree (before/after washing site of observation) between by EIEC members | 1day |
| Coincidence rate between the intestinal cleansing degrees evaluated by EIEC and the endoscope operators (before/after the observed site) | 1day |