Tokyo, Aug. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058826) titled 'Comparative study of human absorption of Q10 formulation -3 (NO fasting condition)' on Aug. 19.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Active
Primary Sponsor:
Institute - KANEKA CORPORATION
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare the absorbability of two Q10 formulations in humans in NO fasting condition.
Basic objectives2 - Bio-equivalence
Intervention:
Interventions/Control_1 - Single intake of test food A,Washout,Single intake of test food B
Interventions/Control_2 - Single intake of test food B,Washout,Single intake of test food A
Eligibility:
Age-lower limit - 20
years-old
Gender - Male
Key inclusion criteria - 1) Healthy males aged of 20-39 years.
2) Subjects whose BMI18.5 kg/m2 <= and <25.0 kg/m2.
3) Subjects who can visit the clinic on the scheduled visit date
4) Subjects who agreed in writing with sufficient understanding of the purpose and contents of this study
Key exclusion criteria - 1) Subjects who have systolic blood pressure <90 mmHg
2) Subjects who donated their blood components and/or whole blood 200mL within the past 4 weeks
3) Subjects who donated their whole blood 400mL within the past 12 weeks
4) Subjects being collected in total of their blood 1,200mL within the past 12 months and in this research
5) Subjects who participated in other clinical studies in the past 4 weeks or who are scheduled to participate in another study during the study period
6) Subjects who meet any of the following:
a) suffering from heart, liver, or kidney disease (including complications of other diseases)
b) having a history of cardiovascular disease
c) diabetes
d) allergic to the test food
e) Subjects with a positive or suspected positive test for infectious diseases
7) Subjects who are under treatment at the time of obtaining consent to participate in the study
8) Subjects who have history of surgery on gastrointestinal part such as gastrectomy, gastrointestinal suture and intestinal resection
9) Subjects who have some kind of food allergy
10) Subjects who have experienced sickness due to blood collection
11) Subjects who have difficulty drawing blood from the peripheral vein
12) Heavy drinker (over 40g alcohol/day)
13) Subjects who quit smoking for less than 6 months or smokers
14) Subjects whose eating habits are extremely irregular
15) Subjects who are shift workers and night workers
16) Subjects who have used medicines within 1 week of ingestion of the test food
17) Subjects who use oral medication or supplements which may affect this study or ingested within 1 month
18) Subjects judged as unsuitable for this study by the principal investigator
Target Size - 7
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 12 Day
Date of IRB - 2025 Year 08 Month 18 Day
Anticipated trial start date - 2025 Year 08 Month 20 Day
Last follow-up date - 2025 Year 09 Month 21 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067270
Disclaimer: Curated by HT Syndication.
