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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018741
Receipt No. R000021683
Scientific Title Pharmacokinetics test of bilberry extract containing food
Date of disclosure of the study information 2015/08/20
Last modified on 2015/12/03

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Basic information
Public title Pharmacokinetics test of bilberry extract containing food
Acronym Pharmacokinetics test of bilberry extract containing food
Scientific Title Pharmacokinetics test of bilberry extract containing food
Scientific Title:Acronym Pharmacokinetics test of bilberry extract containing food
Region
Japan

Condition
Condition healthy subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the pharmacokinetics of bilberry extract administration
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the pharmacokinetic parameters of anthocyanins in plasma
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Food
Interventions/Control_1 1)Bilberry extract 160mg containing single administration
2)Bilberry extract 320mg containing single administration
3)Bilberry extract 480mg containing single administration
Interventions/Control_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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
49 years-old >=
Gender Male and Female
Key inclusion criteria 1)healthy volunteer
2)body height: male =>160cm, =< 180cm
female => 150, =< 170
3)BMI: => 19, =< 25
4)non-smoker
Key exclusion criteria 1)Subjects who have previous medical history of drug and/or food allergy.
2)Subjects who have previous medical history and/or current medical history of serious diseases (e.g., diabetes, digestive organ, liver, pancreas, heart and/or kidney).
3)Subjects who have been enrolled in the other clinical trials within about last 1 month.
4)Subjects who predicted gluttony and irregular eating habits by the pre-questionnaire and doctor's questions.
5)Subjects who has made a meal in the morning of the test day.
6)Subjects who constantly use supplements and/or functional foods affecting eyestrain.
7)Subjects who take medicines and plan to take new health foods.
8)Subjects who drank alcohol when test the day before.
9)Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Marie Kosehira
Organization Omnica Co.,Ltd
Division name Research team
Zip code
Address TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5840-9811
Email kosehira@omnica.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Marie Kosehira
Organization Omnica Co.,Ltd
Division name Research team
Zip code
Address TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5840-9811
Homepage URL
Email kosehira@omnica.co.jp

Sponsor
Institute HUMA R&D Co.
Institute
Department

Funding Source
Organization Omnica Co.,Ltd
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
2015 Year 08 Month 20 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
2015 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 21 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
2015 Year 08 Month 20 Day
Last modified on
2015 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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