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| Name | Class |
|---|---|
| Pierrel Research Europe GmbH | INDUSTRY |
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This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, arm 1 | Experimental | Evening dose 1 plus fixed morning dose |
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| Part A, arm 2 | Experimental | Evening dose 2 plus fixed morninf does |
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| Part A, arm 3 | Experimental | Evening dose 3 plus fixed morning dose |
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| Part A, arm 4 | Active Comparator | Moviprep |
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| Part B, arm 1 | Experimental | Fixed evening dose plus morning dose 1 |
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| Part B, arm 2 | Experimental | Fixed evening dose plus morning dose 2 |
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| Part B, arm 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NER1006 | Drug | Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Variable | Stool weight output generated from the start of intake for the following 24 hours. | 36 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| PEG3350 concentration | Concentration of PEG3350 in blood, urine and faeces. | 96 Hours |
| Sulphate concentration | Concentration of PEG3350 in blood, urine and faeces. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodica Cinca, MD | Pierrel Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pierrel Research HP-RO-SRL | Timișoara | 300244 | Romania | |||
| Pierrel Research HP-RO-SRL |
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| Experimental |
Fixed evening dose plus morning dose 3 |
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| Part B, arm 4 | Experimental | Fixed evening dose plus alternative morning dose |
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| NER1006 | Drug | Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid. |
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| NER1006 | Drug | Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid. |
|
| Moviprep | Drug | Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning. |
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| NER1006 | Drug | Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate. |
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| NER1006 | Drug | Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate. |
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| NER1006 | Drug | Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate. |
|
| NER1006 | Drug | Single evening dose containing formulation selected from Part A of study. Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid. |
|
| 96 hours |
| Ascorbic acid concentration | Concentration of ascorbic acid in blood, urine and faeces. | 96 hours |
| Electrolytes concentration | Concentration of electrolytes in blood, urine and faeces. | 96 hours |
| Safety profile | Spontaneouly reported adverse events will be recorded throughout the study | 96 hours |
| Timișoara |
| Romania |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C520497 | MoviPrep |
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