Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

161

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

September 30, 2011

Study Completion Date

December 31, 2011

Conditions
Colorectal Cancer
Interventions
DRUG

NER1006

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.

DRUG

NER1006

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.

DRUG

NER1006

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.

DRUG

Moviprep

Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.

DRUG

NER1006

Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.

DRUG

NER1006

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.

DRUG

NER1006

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.

DRUG

NER1006

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.

Trial Locations (2)

300244

Pierrel Research HP-RO-SRL, Timișoara

Unknown

Pierrel Research HP-RO-SRL, Timișoara

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Pierrel Research Europe GmbH

INDUSTRY

lead

Norgine

INDUSTRY

NCT01834742 - Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects | Biotech Hunter | Biotech Hunter