NCT00896246

Scintigraphic Assessment Following Klean-Prep® or Moviprep®

Scintigraphic Assessment of Gastrointestinal Transit Following Administration of Klean-Prep® (4L) or Moviprep® (2L) to Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Norgine · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastric Emptying
• Healthy

Interventions

Type	Name	Description
DRUG	Klean-Prep®	Four litres of solution administered orally as a divided dose.
DRUG	Moviprep®	Two litres of solution administered orally as a divided dose

Timeline

• Start date: 2006-09-01
• Primary completion: 2006-10-01
• Completion: 2006-11-01
• First posted: 2009-05-11
• Last updated: 2009-05-12

Locations

1 site across 1 country: United Kingdom