Ulcerative Colitis
Conditions
Interventions
Z-206 1.2g/day group: One Z-206 400mg tablet and 2 Z-206 placebo tablets per time (total 3 tablets). Three times a day (t.i.d.) after each meal for total of 19 administrations. In the morning of day
Sponsors
Zeria Pharmaceutical Co., LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Healthy male adults whose age is 20 years or older but less than 50 years old at the time of obtaining informed consent and whose BMI values are 17.6 to 26.4 2)Subjects who can understand the contents of this trial and can give consents in writing to participate in this trial
Exclusion criteria
Exclusion criteria: 1)Subjects with hypersensitivity to drugs, drug dependency, or alcohol dependency or history of such 2)Subjects currently suffering from impediments of the digestive organs, disorders of the liver, renal disorders, hematological disorders, circulatory system diseases, mental or nervous disorders, etc., which are considered to be inappropriate for the participation in trial or history of such 3)Subjects with HBs antigen, HCV antibody, HIV antigen antibody, and positive syphilis serum test 4)Subjects taking a drug(s) within 1 week of the administration of the trial drug 5)Subjects receiving administration of any trial drug within 4 months prior to the trial drug administration 6)Subjects who received whole blood collection of 200 mL within 1 month before the trial drug administration or component blood collection within 2 weeks or blood collection of 400 mL or more (such as blood donation) within 3 months 7)Others, subjects judged by the principal investigator or co-investigators to be inappropriate for participation in this drug trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The drug concentration in the mucous membrane of the large intestines | — |
Countries
Japan
Contacts
Public ContactZeria Pharmaceutical Co., LTD.
Zeria Pharmaceutical Co., LTD. Clinical Research
Outcome results
None listed