Scintigraphic Assessment Following Klean-Prep® or Moviprep®
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 Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Scintigraphic Assessment of Gastrointestinal Transit Following Administration of Klean-Prep® (4L) or Moviprep® (2L) to Healthy Volunteers.|
- 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 ] [ Designated as safety issue: No ]
- To assess the gastrointestinal transit of Moviprep® and Klean-Prep® in comparison to baseline [ Time Frame: 2-4 days ] [ Designated as safety issue: No ]
- To determine gastric emptying of Moviprep® and Klean-Prep® [ Time Frame: 2-4 days ] [ Designated as safety issue: No ]
- To collect information about stool weight, visual characteristics and distribution of the radiolabel [ Time Frame: 2-4 days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||November 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Active Comparator: Klean-Prep®
1 x gelatin capsule containing not more than 1 MBq 111In radiolabelled ion exchange resin plus Klean-Prep® (4 L) containing 99mTc-DTPA administered as a divided dose.
Four litres of solution administered orally as a divided dose.
1 x gelatin capsule containing not more than 1 MBq 111In radiolabelled ion exchange resin plus Moviprep® (2 L) containing radiolabelled 99mTc-DTPA administered as a divided dose.
Two litres of solution administered orally as a divided dose
|Pharmaceutical Profiles Ltd|
|Nottingham, United Kingdom, NG11 6JS|
|Study Director:||Hans-Jürgen Gruss, MD||Norgine|
|Principal Investigator:||Philip Evans, MB ChB MRCS||Pharmaceutical Profiles Ltd|