Healthy Volunteers
Conditions
Interventions
24mcg of Lubiprostone once daily after lunch for 14 days or 28 days
No treatment for 14 days or 28 days
Sponsors
Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Men at age >=20 years but <60 years when the consent was obtained 2)Persons who were determined to be healthy adults by the investigator/sub-investigator (hereinafter referred to as investigator, etc.) during medical interview at screening 3)Persons from whom the written consent was obtained and who can abide by the compliance rules while participating in this study, receive medical examination and tests prescribed in this protocol, and report symptoms, etc.
Exclusion criteria
Exclusion criteria: 1)Persons who have received NSAIDs within 3 months before obtaining the consent (excluding topical administration of NSAIDs) 2)Persons with history of food or drug allergy (diclofenac sodium, lubiprostone, etc.) or who are suspected of such allergy 3)Persons with current or history of serious cardiovascular/vascular, hematological, respiratory, liver, kidney, gastrointestinal, or neuropsychiatric disease 4)Persons who are taking proton pump inhibitors (PPIs), antibiotics, or intestinal drugs (excluding topical administration of antibiotics) 5)Persons who have participated in other clinical studies and received the study drug, etc. within 1 month prior to the start of this study (calculated from the administration date of the study drug) 6)Persons who were judged by the investigator, etc. to be inappropriate as a subject for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Permeability of the small intestine using the lactulose/mannitol test | — |
Secondary
| Measure | Time frame |
|---|---|
| Endotoxin activity in blood, changes in the intestinal flora | — |
Countries
Japan
Contacts
Public ContactHiroki Endo
Yokohama City University Department of Gastroenterology and Hepatology
Outcome results
None listed