Pharmacokinetics study of a food containing botanical extract - Randomized crossover study

Not Applicable

• Conditions: ot applicable

• Registration Number: JPRN-UMIN000044073
• Lead Sponsor: Maruzen Pharmaceuticals Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-05-14
• Study Start: 2022-01-01
• Last Update Posted: 17 October 2023

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 weeeks from the start of the study 4)Subjects who donated 1200 mL over or more of 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, digestive organs 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 study 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 allergy related to the foods 10)Subjects who have experienced sickness due to blood collection 11)Subjects who have difficulty drawing blood from the peripheral vein 12)Heavy alcoholic beverager(40g alcohol/day>=) 13)Subjects who quit smoking for less than 6 months or smokers 14)Subjects whose eating habits are extremely irregular 15)Shift worker and night worker 16)Subjects who took medicine before the study 17)Subjects who use oral supplements which may affect this study 18)Subjects who the physician's judgement found difficult to consume the test foods 19)Subjects who are ineligible due to physician's judgement

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration, Maximum time plasma concentration, Area under the plasma concentration-time curve from time zero to the time of the last measurable drug concentration