Phase I/II Clinical Trial of NPF-08 in Healthy Volunteers
Phase I/II Clinical Trial of NPF-08 in Healthy Volunteers
Japanese male healthy volunteers will receive NPF-08. The efficacy of NPF-08 will be assessed
 by intestinal cleaning degree. The safety of NPF-08 will be evaluated based on adverse events
 and adverse drug reactions observed from the date of administration to 7 days after
 administration.
Inclusion Criteria:

 1. Japanese healthy male volunteers (20 to 64 years old)

 2. BMI（Body Mass Index）should be within a range of 17.6 and 26.4.

 3. Subjects who agreed not to smoke or drink during hospital stay.

 4. Subjects who do not excessively consume alcohol and those who do not excessively smoke

 5. Subjects who are not judged as abnormal during the screening period in the physical
 examinations including 12-lead ECG, clinical symptoms, clinical examination,
 immunological examination (hepatitis B examination, hepatitis C examination, AIDS
 examination, syphilis examination).

 6. Subjects who are not judged as abnormal during the before administration in blood
 electrolyte.

 7. Subjects who have no clinical abnormalities and are judged to be eligible to the study
 by the investigator.

 Exclusion Criteria:

 1. Subjects who had previous significant gastrointestinal surgeries.

 2. Subjects with a history of 12-lead ECG abnormality.

 3. Subjects who have constipation（less than 2 bowel movement per week）

 4. Subjects who have addictive of diarrhea

 5. Subjects who have history of shock or hypersensitivity to sulfates (sodium sulfate,
 potassium sulfate, magnesium sulfate, etc.).

 6. Subjects who have history of drug allergy.

 7. Subjects who donated 200 mL or 400 mL of whole blood 4 weeks or 12 weeks respectively
 prior to the administration of investigational drug, or who donated blood component
 last 2 weeks.

 8. Subjects who have participated in an investigational study within 4 months before
 signing the consent.

 9. Subjects who is participating in the other investigational study

 10. Subjects who received NPF-08 in the past

 11. Subjects who are judged by the investigator as not adequate to participate the study.