Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063275) titled 'Pharmacokinetics study of food ingredient' on Oct. 14.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
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 intake
Eligibility:
Age-lower limit - 20
years-old
Gender - Male
Key inclusion criteria - (1) Japanese 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 and =200 mL of blood (component or whole blood) within 4 weeks before the study begins
3 Those who donated/plan to donate >=400 mL of whole blood within 12 weeks before the study begins
4 Those whose total blood donation volume during the 12 months before the study, plus planned blood collection in this study, exceeds 1,200 mL
5 Those participating in another study, within 4 weeks after completing another study, or planning to participate in another study during this study
6 Those with heart, liver, or kidney disease (including complications); history of cardiovascular disease; diabetes; allergy to test food, including load food or controlled diet; or history of serious disease such as cancer or tuberculosis
7 Those receiving any medical treatment at screening
8 Those with reduced renal function
9 Those with severe drug or food allergies
10 Those who previously experienced discomfort or deterioration in physical condition due to blood collection
11 Those for whom peripheral venous blood collection is difficult
12 Those whose average daily alcohol consumption exceeds 60 g of pure alcohol
13 Those who smoke or quit smoking less than 3 months ago
14 Those with extremely irregular eating habits
15 Those who work shifts or night shifts
16 Those who regularly use pharmaceuticals, quasi-drugs, Foods for Specified Health Uses, Foods with Function Claims, or health foods
17 Those whose screening results for syphilis, HBs antigen, HCV antibody, or HIV antigen/antibody are not negative
18 Those judged unsuitable as study subjects by the principal investigator or sub-investigator
Target Size - 24
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 09 Month 10 Day
Date of IRB - 2026 Year 09 Month 15 Day
Anticipated trial start date - 2026 Year 09 Month 24 Day
Last follow-up date - 2026 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072426
Disclaimer: Curated by HT Syndication.
