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®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
161
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.
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.
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.
Pierrel Research HP-RO-SRL
Timișoara, Romania
Pierrel Research HP-RO-SRL
Timișoara, Romania
Primary Variable
Stool weight output generated from the start of intake for the following 24 hours.
Time frame: 36 Hours
PEG3350 concentration
Concentration of PEG3350 in blood, urine and faeces.
Time frame: 96 Hours
Sulphate concentration
Concentration of PEG3350 in blood, urine and faeces.
Time frame: 96 hours
Ascorbic acid concentration
Concentration of ascorbic acid in blood, urine and faeces.
Time frame: 96 hours
Electrolytes concentration
Concentration of electrolytes in blood, urine and faeces.
Time frame: 96 hours
Safety profile
Spontaneouly reported adverse events will be recorded throughout the study
Time frame: 96 hours
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Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.
Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
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.
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.
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.