Tokyo, March 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060946) titled 'Investigation of the pharmacokinetics following oral administration of the test food' on March 16.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Pharma Foods International Co., Ltd.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the pharmacokinetics of the test food following oral administration Basic objectives2 - Bio-equivalence

Intervention: Interventions/Control_1 - Single intake of the test food

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Japanese 2.Men or women 3.Adults 4.Healthy individuals Key exclusion criteria - 1.Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2.Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3.Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, metabolic bone disorders, including osteoporosis and fractures, or any other chronic diseases 4.Individuals who are taking medications that affect the gastrointestinal system (including Kampo medicines) and/or supplements containing peptides or amino acids 5.Individuals who are allergic to medicines or foods related to the test product, particularly those allergic to eggs 6.Individuals whose BMI is less than 18.5 kg/m2 or 30 kg/m2 or more 7.Individuals who are undergoing exercise or alimentary therapy under medical supervision 8.Individuals who have a present condition or have a medical history of drug or alcohol dependence 9.Individuals who are undergoing treatment for psychiatric disorder (including depressive symptoms) or sleep disorder 10.Individuals who are pregnant, lactating, or planning to become pregnant during this study 11.Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 12.Individuals who are judged as ineligible to participate in this study by the physician Target Size - 5

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 02 Month 25 Day Date of IRB - 2026 Year 03 Month 05 Day Anticipated trial start date - 2026 Year 03 Month 16 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069746

Disclaimer: Curated by HT Syndication.