Status:
COMPLETED
Phase I/II Clinical Trial of NPF-08 in Healthy Volunteers
Lead Sponsor:
Nihon Pharmaceutical Co., Ltd
Conditions:
Healthy Volunteers
Eligibility:
MALE
20-64 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2018
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03423771
Start Date
October 6 2017
End Date
February 28 2018
Last Update
April 18 2018
Active Locations (1)
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1
Osaka
Osaka, Japan