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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Four litres of solution administered orally as a divided dose.
Two litres of solution administered orally as a divided dose
Pharmaceutical Profiles Ltd
Nottingham, United Kingdom
To assess the impact of Moviprep® and Klean-Prep® on time of colonic transit of the contents of the colon in comparison to baseline
Time frame: 2-4 days
To assess the gastrointestinal transit of Moviprep® and Klean-Prep® in comparison to baseline
Time frame: 2-4 days
To determine gastric emptying of Moviprep® and Klean-Prep®
Time frame: 2-4 days
To collect information about stool weight, visual characteristics and distribution of the radiolabel
Time frame: 2-4 days
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