Phase I/II Clinical Trial of NPF-08 in Healthy Volunteers

Inclusion criteria

• Japanese healthy male volunteers (20 to 64 years old)
• BMI（Body Mass Index）should be within a range of 17.6 and 26.4.
• Subjects who agreed not to smoke or drink during hospital stay.
• Subjects who do not excessively consume alcohol and those who do not excessively smoke
• 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).
• Subjects who are not judged as abnormal during the before administration in blood electrolyte.
• Subjects who have no clinical abnormalities and are judged to be eligible to the study by the investigator.

Exclusion criteria

• Subjects who had previous significant gastrointestinal surgeries.
• Subjects with a history of 12-lead ECG abnormality.
• Subjects who have constipation（less than 2 bowel movement per week）
• Subjects who have addictive of diarrhea
• Subjects who have history of shock or hypersensitivity to sulfates (sodium sulfate, potassium sulfate, magnesium sulfate, etc.).
• Subjects who have history of drug allergy.
• 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.
• Subjects who have participated in an investigational study within 4 months before signing the consent.
• Subjects who is participating in the other investigational study
• Subjects who received NPF-08 in the past
• Subjects who are judged by the investigator as not adequate to participate the study.