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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Klean-Prep® | Active Comparator | 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. |
|
| Moviprep® | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Klean-Prep® | Drug | Four litres of solution administered orally as a divided dose. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the impact of Moviprep® and Klean-Prep® on time of colonic transit of the contents of the colon in comparison to baseline | 2-4 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the gastrointestinal transit of Moviprep® and Klean-Prep® in comparison to baseline | 2-4 days | |
| To determine gastric emptying of Moviprep® and Klean-Prep® | 2-4 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans-Jürgen Gruss, MD | Norgine | Study Director |
| Philip Evans, MB ChB MRCS | Pharmaceutical Profiles Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Profiles Ltd | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| C112283 | klean prep |
| C520497 | MoviPrep |
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| Moviprep® |
| Drug |
Two litres of solution administered orally as a divided dose |
|
| To collect information about stool weight, visual characteristics and distribution of the radiolabel |
| 2-4 days |