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
1. The subject's written informed consent must be obtained prior to inclusion.
2. Healthy subjects with an age of 18 to 45 years.
3. 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.
4. 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.
5. Willing, able and competent to complete the entire procedure and to comply with study
1. Use of laxatives in the last 12 months or colon motility altering drugs in the last 6
2. 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
3. Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of
4. 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]).
5. Exhibiting relevant abnormal gastrointestinal motility according to clinical
judgement in the past or now.
6. 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.
7. Known glucose-6-phosphatase dehydrogenase deficiency.
8. Known phenylketonuria.
9. History or evidence of any clinical significant systemic cardiovascular, hepatic,
pulmonal, neurological, metabolic and/or renal organ dysfunction.
10. History of clinically significant drug allergy; history of atopic allergy (asthma,
urticaria, eczematous dermatitis), known hypersensitivity to polyethylene glycols
and/or ascorbic acid.
11. History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities
12. Evidence of dehydration.
13. Any evidence for abnormal sodium or potassium levels or clinically significant other
14. 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
15. Clinically relevant findings on physical examination based on Investigator's
16. Clinically relevant deviations of laboratory parameters from reference ranges at
screening or check-in evaluation.
17. Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV)
18. 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
19. Subjects who are unwilling to comply with the provisions of the study protocol.
20. Concurrent participation in an investigational drug study or participation within 3
month of study entry.
21. 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
22. Previous participation in the study.