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

UMIN ID: UMIN000034637

Registered date:26/10/2018

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 2018/10/29
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Oral intake of the test food for 5 days (3 times a day, 13 times in all)

Outcome(s)

• Primary Outcome: Cmax Tmax AUC

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 60years-old
• Gender: Male
• Exclude criteria: 1) 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

• Primary Sponsor: Zenyaku Kogyo Co., Ltd.
• Secondary Sponsor: HUMA R&D CORP
• Source(s) of Monetary Support: Zenyaku Kogyo Co., Ltd.