NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000034637

Registered date:26/10/2018

A pharmacokinetics study of the major ingredient and its metabolites after multiple ingestions of test food

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedNot applicable
Date of first enrollment2018/10/29
Target sample size5
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Oral intake of the test food for 5 days (3 times a day, 13 times in all)

Outcome(s)

Primary OutcomeCmax Tmax AUC
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum30years-old
Age maximum60years-old
GenderMale
Include criteria
Exclude criteria1) Subjects who are in a continuing treatment with a prescription drug for over a month. 2) Subjects who intake of a prescription drug or an over-the-counter drug within a last week. 3) Subjects who does not meet the following clinical testing criteria; AST and ALT below 30 U/L, gamma-GTP below 50 U/L. 4) Subjects who are deemed to be unsuitable by the physician- in-charge.

Related Information

Contact

public contact
Name Takeshi Nagata
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650, Japan
Telephone +81-3-3946-1112
E-mail Takeshi_Nagata@mail.zenyaku.co.jp
Affiliation Zenyaku Kogyo Co., Ltd. Consumer Products Planning Section, Consumer Products Planning Department
scientific contact
Name Masaaki Takehara
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo
Telephone +81-3-3946-1112
E-mail Masaaki_Takehara@mail.zenyaku.co.jp
Affiliation Zenyaku Kogyo Co., Ltd. Consumer Products Planning Department