UMIN-CTR Clinical Trial

Public title

Pharmacokinetic comparative study of Isoquercitrin in healthy male volunteers

Acronym

Pharmacokinetic comparative study of Isoquercitrin in healthy male volunteers

Scientific Title

Pharmacokinetic comparative study of Isoquercitrin in healthy male volunteers

Scientific Title:Acronym

Pharmacokinetic comparative study of Isoquercitrin in healthy male volunteers

Region

Japan

Condition

Healthy male adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Comparing bioavailability among test foods

Basic objectives2

Bio-availability

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

AUCt and Cmax calculated from plasma component concentrations at ingestion of test food

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Single ingestion of test food(1), Washout(14 days or more), Single ingestion of test food(2), Washout(14 days or more), Single ingestion of test food(3)

Interventions/Control_2

Single ingestion of test food(1),Washout(14 days or more), Single ingestion of test food(3), Washout(14 days or more), Single ingestion of test food(2)

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

40

years-old

>=

Gender

Male

Key inclusion criteria

1) Japanese healthy male volunteers with 20 to 40 years of age when written informed consent is obtained
2) Subjects with BMI of 18.5 and above to below 25.0 at screening test
3) Subjects who are judged as eligible in the screening test by the principal (or sub) doctor
4) Subjects who realize the object and contents of the study and submit the written informed consent

Key exclusion criteria

1) Subjects who have a disease under treatment
2) Subjects who are sensitive to drugs or food , or have idiosyncrasy or the history of idiosyncrasy
3) Subjects with allergy disease such as bronchial asthma, pollenosis, atopic dermatitis etc
4) Subjects who have diseases of heart, liver, kidney, digestive organs, respiratory organs and blood function or the history of the diseases or the severe operation history of the diseases and are judged as ineligible to participate in the study by the principal (or sub) doctor (excluding extirpation of appendicitis)
5) Subjects with positive reaction in immunological serum testing at screening test
6) Subjects who take foods for specified health uses , foods with function claims and foods with nutrient function claims (supplements in capsule form and others), excluding those who can stop taking those foods after informed consent)
7) Subjects who cannot keep no smoking in hospital and temperance from 2 days before
8) Subjects who used drugs or took drugs within one week before ingestion of test food or need to use drugs or take drugs in the first period
9) Subjects who participated in other clinical trials and received medication within 12 weeks before ingestion of test food in the first period
10) Subjects who donated 400 mL or 200 mL of blood within 12 or 4 weeks before ingestion of test food or have the schedule of donation of blood component (plasma or platelet) or donated the component within 2 weeks before ingestion of test food in the first period
11) Subjects who are judged as ineligible to participate in the study for other reasons by the principal (or sub) doctor

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Susumu Ishikawa

Organization

Medical Corporation Shoureikan Sinsapporo seiryou Hospital

Division name

internal medicine

Zip code

Address

2-1-30, Atsubetsuhigashi 4jo, Atsubetsu-ku, Sapporo, Hokkaido, Japan

TEL

011-898-2151

Email

chiken-be@hpgr.jp

Name of contact person

1st name
Middle name
Last name	Shimpei Tomita

Organization

New drug research center, Inc.

Division name

Clinical Research Dept.

Zip code

Address

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

TEL

0123-34-0412

Homepage URL

Email

s-tomita@ndrcenter.co.jp

Institute

Alps Pharmaceutical Inc. Co., Ltd.

Institute

Department

Personal name

Organization

Alps Pharmaceutical Inc. Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2018

Year

08

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

2018

Year

07

Month

27

Day

Date of IRB

Anticipated trial start date

2018

Year

08

Month

28

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

08

Month

28

Day

Last modified on

2018

Year

11

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038696