Tokyo, May 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061419) titled 'Pharmacokinetics study of food ingredient' on May 12.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Dose comparison
Primary Sponsor:
Institute - Suntory Holdings Limited
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the pharmacokinetics of food ingredient
Basic objectives2 - Bio-equivalence
Intervention:
Interventions/Control_1 - Food 1 intake -> washout period -> Food 2 intake -> washout period -> Food 3 intake -> washout period -> Food 4 intake
Interventions/Control_2 - Food 2 intake -> washout period -> Food 3 intake -> washout period -> Food 4 intake -> washout period -> Food 1 intake
Eligibility:
Age-lower limit - 20
years-old
Gender - Male
Key inclusion criteria - (1) Males who are 20 years of age or older at the time of obtaining consent and under 65 years of age at the end of the intake period
(2) Individuals whose BMI at the screening test is 18.5~30
(3) Individuals who are not receiving any medical treatment at the time of study participation
(4) Individuals who are able to visit the designated facility on the scheduled visit days
(5) Individuals who fully understand the purpose and details of this study and provide written informed consent
Key exclusion criteria - (1) Individuals whose systolic blood pressure at the screening test is below 90 mmHg
(2) Individuals who have donated (or are scheduled to donate) 200 mL or more of blood, either as component donation or whole blood, from 4 weeks before the start of the study until the study begins
(3) Individuals who have donated (or are scheduled to donate) 400 mL or more of whole blood from 12 weeks before the start of the study until the study begins
(4) Individuals whose total blood donation volume from the month 12 months prior to the study start up to the study start, plus the planned total blood collection volume for this study, exceeds 1,200 mL
(5) Individuals who are currently participating in another study as study subjects, who have participated in another study within 4 weeks after its completion, or who plan to participate in another study during the study period
(6) Individuals with a history of serious diseases
(7) Individuals who are receiving any kind of medical treatment at the time of the screening test
(8) Individuals with reduced renal function
(9) Individuals with severe drug or food allergies
(10) Individuals who have previously experienced discomfort or deterioration of physical condition due to blood collection
(11) Individuals for whom venous blood collection from peripheral veins is difficult
(12) Individuals whose average daily alcohol consumption exceeds 60 g of pure alcohol
(13) Individuals who smoke or have quit smoking for less than 3 months
(14) Individuals with extremely irregular eating habits
(15) Individuals who work in shifts or work night shifts
(16) Individuals who are judged by the principal investigator or sub-investigator to be unsuitable as study subjects
Target Size - 28
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 30 Day
Anticipated trial start date - 2026 Year 05 Month 13 Day
Last follow-up date - 2026 Year 07 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070277
Disclaimer: Curated by HT Syndication.
