Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059605) titled 'Pharmacokinetic Evaluation of Bioactive Components in a Test Substance Administered to Healthy Adults' on Nov. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Otsuka Pharmaceutical Co., Ltd.

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

Objective: Narrative objectives1 - To evaluate the pharmacokinetics of the constituent compounds contained in the test substance following its administration to healthy adult subjects. Basic objectives2 - Pharmacokinetics

Intervention: Interventions/Control_1 - Administration of test food

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1) Individuals who provided written informed consent to participate in the study. 2) Healthy Japanese adults aged between 20 and 69 years at the time of consent. 3) Postmenopausal women. 4) Individuals who were able to visit the study site and undergo the required examinations on the designated test days. Key exclusion criteria - 1) Individuals deemed unsuitable for participation in the study by the investigator based on clinical laboratory tests or physical examinations. 2) Individuals with a history of serious disorders affecting major organs or systems, or those currently undergoing treatment, who are considered unsuitable for the study by the investigator. 3) Individuals with a current or past history of drug or food allergies. 4) Individuals who regularly take medications, including traditional Japanese (Kampo) medicines. 5) Individuals scheduled to receive any vaccination during the study period. 6) Individuals who donated 200 mL or more of whole blood within 4 weeks prior to the start of test food intake, or 400 mL or more within 12 weeks prior to the start of test food intake. 7) Individuals who tested positive for any of the following: HBs antigen, HCV antibody, HIV antigen/antibody, or syphilis serology. 8) Any other individuals deemed inappropriate for participation by the investigator or the study director. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 22 Day Anticipated trial start date - 2025 Year 11 Month 11 Day Last follow-up date - 2025 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068054

Disclaimer: Curated by HT Syndication.