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Scintigraphic Assessment Following Klean-Prep® or Moviprep®

Norgine · 2006
ClinicalTrials.gov · Datasets · License: Public Domain · 2006
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This was a phase 1, open-label, randomized study, designed to assess the impact of Moviprep® or Klean-Prep® on gastrointestinal transit. It was performed in two parallel groups with Part A in two groups of four subjects preceding Part B, which was performed in two groups of 12 subjects. Subjects attended a pre-study medical within 28 days of dosing and a post-study medical 5-10 days after the final dose. Within both Part A and Part B, subjects were required to attend the clinical unit for 2 study periods. Part A consisted of a baseline period to determine individual reference times for gastrointestinal transit. Part B was the test period in which gastrointestinal transit following the administration of the test preparations was assessed.
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