UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Blood concentration confirmation study on silymarin formulation of process materials.
Title of the study (Brief title)	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	Sayuri Matsuoka
Organization	FANCL Corporation
Division name	Research Institute
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	Masaya Tsubokawa
Organization	FANCL Corporation
Division name	Research Institute
Address	Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806
TEL	045-820-3659
Homepage URL
Email	tsubokawa_masaya@fancl.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025739