UMIN-CTR Clinical Trial

Public title

Pharmacokinetics study of functional food
- Randomized crossover study -

Acronym

Pharmacokinetics study of functional food

Scientific Title

Pharmacokinetics study of functional food
- Randomized crossover study -

Scientific Title:Acronym

Pharmacokinetics study of functional food

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the pharmacokinetics of functional food

Basic objectives2

Bio-availability

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Single ingestion of test food 1 -> Washout(1day) -> Single ingestion of test food 2

Interventions/Control_2

Single ingestion of test food 2 -> Washout(1day) -> Single ingestion of test food 1

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

39

years-old

>=

Gender

Male

Key inclusion criteria

1)Males equal to or more than 20 years and less than 39 years of age
2)Subjects who BMI18.5=> kg/m2 and <30.0kg/m2
3)Subjects who visit on schedule days
4)Subjects who recognize the object and contents of the study and submit the written informed consent

Key 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

Target sample size

16

Name of lead principal investigator

1st name	Hideaki
Middle name
Last name	Hoshino

Organization

Medical Corporation Jikokai Shiroishi Internal Medicine Clinic

Division name

General Medicine Clinical Departments: Internal Medicine Respiratory Medicine Allergy

Zip code

003-0011

Address

7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan

TEL

011-868-2711

Email

n-abe@medi-ate.jp

Name of contact person

1st name	Toyotada
Middle name
Last name	Ashino

Organization

New drug research center, Inc.

Division name

Clinical Research Dept.

Zip code

061-1405

Address

452-1 Toiso,Eniwa-shi,Hokkaido, Japan

TEL

0123-34-0412

Homepage URL

Email

t-ashino@ndrcenter.co.jp

Institute

Maruzen Pharmaceuticals Co., Ltd.

Institute

Department

Personal name

Organization

Maruzen Pharmaceuticals Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Corporation Jikokai Shiroishi Internal Medicine Clinic Clinical Trial Review Committee

Address

1-2-5 Itoyokado Fukuzumiten-5F Fukuzumi-2 jo, Toyohira-ku, Sapporo, Hokkaido, Japan

Tel

011-836-3531

Email

s-fukui@jikokai.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

12

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

16

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2021

Year

11

Month

09

Day

Date of IRB

2021

Year

11

Month

15

Day

Anticipated trial start date

2021

Year

12

Month

11

Day

Last follow-up date

2021

Year

12

Month

13

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

11

Month

18

Day

Last modified on

2022

Year

10

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052625