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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
90
Drug: NPF-08 Arms: NPF-08 oral sulfate solution
Osaka
Osaka, Japan
Effective rate of overall intestinal cleaning effect (after washing of the observed region) by the Endoscopic Image Evaluation Committee (EIEC)
Time frame: 1day
Effective rate of overall intestinal cleaning effect (before washing of observed site) by EIEC
Time frame: 1day
Cleaning effect by intestinal site (before/after washing of observed site)
Time frame: 1day
Degree of bubbles by intestinal site
Time frame: 1day
Time for completion of the bowel cleaning
Time frame: 1day or 2day
Total dose of the investigational drug
Time frame: 1day
Acceptability by subjects
Time frame: up to 6hr
Coincidence rate of intestinal cleansing degree (before/after washing site of observation) between by EIEC members
Time frame: 1day
Coincidence rate between the intestinal cleansing degrees evaluated by EIEC and the endoscope operators (before/after the observed site)
Time frame: 1day
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