MedPath

Pharmacokinetics study of functional food - Randomized crossover study

Not Applicable
Conditions
Healthy volunteer
Registration Number
JPRN-UMIN000046114
Lead Sponsor
Maruzen Pharmaceuticals Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Male
Target Recruitment
16
Inclusion Criteria

Not provided

Exclusion Criteria

1)Subjects who have systolic blood pressure <90 mmHg 2)Subjects who donated 200 mL or more of blood within 4 weeks from the start of the study 3)Subjects who donated 400 mL or more of blood within 12 weeks from the start of the study 4)Subjects who donated over 1200 mL blood within 12 months from the start of the study 5)Subjects who participated in other clinical studies in the past 4 weeks 6)Subjects who fall under any of the following items a) Subjects who have a history of severe illness and current medical history in the heart, liver, kidney b) Subjects who are under treatment or have a history of cardiovascular disease c) Subjects who develop diabetes d) Subjects who have allergy related to the test foods 7)Subjects who are under treatment 8)Subjects who have history of surgery on gastrointestinal part such as gastrectomy, gastrointestinal suture and intestinal resection 9)Subjects who have stomach upset and stomach discomfort 10)Subjects who have allergy to the foods 11)Subjects who have experienced sickness due to blood collection 12)Subjects who have difficulty drawing blood from the peripheral vein 13)Heavy drinker (over 40g alcohol/day) 14)Subjects who quit smoking for less than 6 months or smokers 15)Subjects whose eating habits are extremely irregular 16)Shift worker and night worker 17)Subjects who took medicine before the study 18)Subjects who use oral supplements which may affect this study 19)Subjects who are ineligible due to physician's judgement

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath