Scintigraphic Assessment Following Klean-Prep® or Moviprep®
Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
Summary
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.