Completed
An Exploratory Phase I/II Study on Safety, Pharmacokinetics and Efficacy of NPF-08 in Healthy Volunteers
What is being tested
NPF-08
Drug
Who is being recruted
From 20 to 64 Years
+18 Eligibility Criteria
How is the trial designed
Diagnostic Study
Phase 1 & 2
Interventional
Study Start: October 2017
Summary
Principal SponsorNihon Pharmaceutical Co., Ltd
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 6, 2017
Actual date on which the first participant was enrolled.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.
Official TitleAn Exploratory Phase I/II Study on Safety, Pharmacokinetics and Efficacy of NPF-08 in Healthy Volunteers
Principal SponsorNihon Pharmaceutical Co., Ltd
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Male
Biological sex of participants that are eligible to enroll.From 20 to 64 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
7 inclusion criteria required to participate
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
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11 exclusion criteria prevent from participating
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
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
7 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
ExperimentalGroup 6
ExperimentalGroup 7
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center