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

Inclusion criteria

• The subject's written informed consent must be obtained prior to inclusion.
• Healthy subjects with an age of 18 to 45 years.
• Healthy subjects need to be without any history of clinical significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
• Females must be surgically sterile, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive implants, injectables, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in.
• Willing, able and competent to complete the entire procedure and to comply with study instructions.

Exclusion criteria

• Use of laxatives in the last 12 months or colon motility altering drugs in the last 6 months.
• Use of any prescription or over-the-counter (OTC) medication within 4 weeks prior to the first dose of investigational drug (excluding hormonal contraception, and occasional use of nonsteroidal anti-inflammatory drugs [NSAID], acetaminophen or metamizole).
• Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
• Any evidence of the history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome [IBS], inflammatory bowel disease [IBD]).
• Exhibiting relevant abnormal gastrointestinal motility according to clinical judgement in the past or now.
• History or presence of any clinically significant acute illness within the 4 weeks prior to the first dose of investigational drug based on clinical judgement at screening and check-in evaluation.
• Known glucose-6-phosphatase dehydrogenase deficiency.
• Known phenylketonuria.
• History or evidence of any clinical significant systemic cardiovascular, hepatic, pulmonal, neurological, metabolic and/or renal organ dysfunction.
• History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis), known hypersensitivity to polyethylene glycols and/or ascorbic acid.
• History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and hypertension.
• Evidence of dehydration.
• Any evidence for abnormal sodium or potassium levels or clinically significant other electrolyte disturbances.
• Females who are pregnant, having a positive pregnancy test at screening and/or admission to unit or planning a pregnancy. Females not using reliable methods of birth control.
• Clinically relevant findings on physical examination based on Investigator's judgement.
• Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation.
• Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening.
• History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or check-in evaluations.
• Subjects who are unwilling to comply with the provisions of the study protocol.
• Concurrent participation in an investigational drug study or participation within 3 month of study entry.
• Subject has a condition or is in a situation, which in the Investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
• Previous participation in the study.