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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033928
Receipt No. R000038696
Scientific Title Pharmacokinetic comparative study of Isoquercitrin in healthy male volunteers
Date of disclosure of the study information 2018/08/28
Last modified on 2018/11/28

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Basic information
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
Condition Healthy male adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparing bioavailability among test foods
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AUCt and Cmax calculated from plasma component concentrations at ingestion of test food
Key secondary outcomes

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Alps Pharmaceutical Inc. Co., Ltd.
Institute
Department

Funding Source
Organization Alps Pharmaceutical Inc. 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
2018 Year 08 Month 28 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
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
Other related information

Management information
Registered date
2018 Year 08 Month 28 Day
Last modified on
2018 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038696

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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