Scintigraphic Assessment Following Klean-Prep® or Moviprep®
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.
Timeline
- Start
- 2006-09
- Primary completion
- 2006-10
- Completion
- 2006-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Klean-Prep® | Other / unclassified | 4000 ml | Oral |
| Subject | Moviprep | Other / unclassified | 2000 ml | Oral |
Indications
No indication recorded.