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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034637

Enrollment

Registered

2018-10-26

Start date

2018-10-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Oral intake of the test food for 5 days (3 times a day, 13 times in all)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Age: 30 and over, below 60. 2) Sex: Japanese males 3) Understanding the study intent and purpose and submitting the written informed consent before study. 4) Subjects who are negative for HBs antigen/antibody, HCV antibody, HIV antigen/antibody, syphilis antigen tests.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Cmax Tmax AUC	—

Countries

Japan

Contacts

Public ContactTakeshi Nagata

Zenyaku Kogyo Co., Ltd. Consumer Products Planning Section, Consumer Products Planning Department

Takeshi_Nagata@mail.zenyaku.co.jp+81-3-3946-1112

Outcome results