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薬理と治療
Abstract
SUPREP® is a sulfate-based bowel cleaning solution for preparation of colonoscopy developed in the United States, has been marketed widely in US, Europe and other regions. However, SUPREP® is not currently marketed in Japan. In this study, we imported and used SUPREP® for NPF-08 to assess the safety and efficacy in Japanese healthy adult male subjects. This study consisted of 4 steps. In Steps 1 to 3, to assess safety and pharmacokinetics of sulfate ion, 50 subjects were administered from 480 mL up to 960 mL of NPF-08 and a double volume of water in one day(Same-day dose regimen)or 480 mL of NPF︱08 and 960 mL of water on the first day and up to 480 mL of NPF︱08 and a double volume of water on the second day(Two-day split-dose regimen). In Step 4, to assess safety, 40 subjects were administered under Same-day dose regimen on the day of colonoscopy or under Two-day split-dose regimen until the stool becomes clear. To assess the bowel cleaning efficacy, the subjects underwent colonoscopy. There were no serious adverse events, and all subjects completed the study drug administration except one who had vomiting. The subject who had vomiting dropped out but recovered immediately without treatment. No abnormalities in the pharmacokinetics and no accumulation of sulfate ions were observed. The bowel cleansing efficacy rate was 100.0%(40/40)on both Same-day dose regimen and Two-day split-dose regimen. Based on the above results, NPF-08 is a safe and useful bowel cleaning preparation for colonoscopy. (ClinicalTrials.gov Identifer:NCT03423771)
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