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Overdose safety test

Overdose safety test - Overdose safety test

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055527
Enrollment
30
Registered
2024-09-18
Start date
2024-09-19
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

Sponsors

APO PLUS STATION CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [1] Healthy males and females in the age more than 20 and less than 70 years. [2] Subjects who can submit the written informed consent form.

Exclusion criteria

Exclusion criteria: [1] Subjects who are on treatment for a serious illness. [2] Subjects who are being treated or have a history of malignant tumors, heart failure, or myocardial infarction. [3] Subjects with food allergies or those who may be allergic to the test food. [4] Subjects who regularly use licensed drugs or quasi-drugs that may affect the study and who are unable to discontinue their intake during the study period. [5] Subjects who regularly use health foods that may affect the study and who are unable to discontinue their intake during the study period. [6] Subjects who have had blood drawn or donated more than 200 mL of blood within a month or more than 400 mL within 3 months before the screening test. [7] Subjects who may be unable to maintain their daily lifestyle. [8] Subjects who are pregnant or breastfeeding or planning to become pregnant during the study period. [9] Subjects who participated in other clinical trials within 3 months prior to the date of consent, or plan to participate in other clinical trials during the study period. [10] Subjects who are judged as ineligible for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Expression rate of side effects

Secondary

MeasureTime frame
[1] Expression rate of adverse events [2] Results of physical examination, clinical examination (blood test, urinalysis)

Countries

Japan

Contacts

Public ContactSatomi Uetake

APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.

food-contact@apoplus.co.jp03-6777-7789

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026