UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022333
Receipt number R000025739
Scientific Title The Blood concentration confirmation study on silymarin formulation of process materials.
Date of disclosure of the study information 2016/05/17
Last modified on 2016/11/16 09:42:19

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Basic information

Public title

The Blood concentration confirmation study on silymarin formulation of process materials.

Acronym

The Blood concentration confirmation study on silymarin formulation of process materials.

Scientific Title

The Blood concentration confirmation study on silymarin formulation of process materials.

Scientific Title:Acronym

The Blood concentration confirmation study on silymarin formulation of process materials.

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate effects on bioavailability of silymarin

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood silymarin concentration after single ingestion of silymarin formulation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Single ingestion of silymarin formulation of process materials

Interventions/Control_2

Single ingestion of silymarin formulation of raw materials

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

50 years-old >

Gender

Male

Key inclusion criteria

1)Healthy males and females aged 20 to 50 years
2)BMI >=18.5 kg/m2 and <30kg/m2

Key exclusion criteria

1)Subjects who previous serious disease.
2)Subjects who are taking medicine or being treated by a doctor
3)Subjects who previous or present serious disease that affect the digestion or being treated by a doctor because of the digestive tract disease
4)Subjects who plan to receive treatment or medication by a doctor during the study
5)Subjects who has chrysanthemum allergy
6)Subjects who use specified healthy food, supplement containing silymarin within the last one month prior to the current study
7)Subjects who cannot be performed over time blood collection
8)Subjects who are judged as unsuitable for the study by the investigator for other reason

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sayuri Matsuoka

Organization

FANCL Corporation

Division name

Research Institute

Zip code


Address

Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806

TEL

045-820-3449

Email

matsuoka@fancl.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masaya Tsubokawa

Organization

FANCL Corporation

Division name

Research Institute

Zip code


Address

Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806

TEL

045-820-3659

Homepage URL


Email

tsubokawa_masaya@fancl.co.jp


Sponsor or person

Institute

FANCL Corporation

Institute

Department

Personal name



Funding Source

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 17 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 05 Month 11 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 17 Day

Last modified on

2016 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025739


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name