Clinical Pharmacology Study of Z-206 - Study on Drug Concentration in Mucous Membrane of Z-206 in Healthy Male Adults-

UMIN ID: UMIN000000678

Registered date:13/04/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 2007/04/01
• Target sample size: 36
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 3, day 5 and day 7 of administration, it is to be taken under fasting condition.
Z-206 2.4g/day group: Two Z-206 400mg tablets and 1 Z-206 placebo tablet 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 3, day 5 and day 7 of administration, it is to be taken under fasting condition.
Z-206 3.6g/day group: Three Z-206 400mg tablets per time. Three times a day (t.i.d.) after each meal for total of 19 administrations. In the morning of day 3, day 5 and day 7 of administration, it is to be taken under fasting condition.

Outcome(s)

• Primary Outcome: The drug concentration in the mucous membrane of the large intestines

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 50years-old
• Gender: Male
• Exclude 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

Related Information

• Primary Sponsor: Zeria Pharmaceutical Co., LTD.
• Source(s) of Monetary Support: Zeria Pharmaceutical Co., LTD.