UMIN-CTR Clinical Trial

Basic information
Public title	Pharmacokinetic comparative study of plant-derived components in healthy male volunteers
Acronym	Pharmacokinetic comparative study of plant-derived components in healthy male volunteers
Scientific Title	Pharmacokinetic comparative study of plant-derived components in healthy male volunteers
Scientific Title:Acronym	Pharmacokinetic comparative study of plant-derived components 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 oral absorbency 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, Washout(14 days or more), Single ingestion of test food of 2 capsule, Washout(14 days or more), Single ingestion of test food of 4 capsule
Interventions/Control_2	Single ingestion of test food, Washout(14 days or more), Single ingestion of test food of 4 capsule, Washout(14 days or more), Single ingestion of test food of 2 capsule
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 Susumu Middle name Last name Ishikawa
Organization	Medical Corporation Shoureikan Sinsapporo seiryou Hospital
Division name	internal medicine
Zip code	004-0004
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 Shimpei Middle name Last name Tomita
Organization	New drug research center, Inc.
Division name	Clinical Research Dept.
Zip code	061-1405
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	Miyawaki Orthopedic Clinic Industrial Review Board
Address	3-1-6 Ariaketyou,Eniwa-shi,Hokkaido, Japan
Tel	0123-33-4026
Email	d-kameda@mediffom.co.jp

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	2019 Year 06 Month 03 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	10
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	2019 Year 05 Month 08 Day
Date of IRB	2019 Year 05 Month 20 Day
Anticipated trial start date	2019 Year 06 Month 03 Day
Last follow-up date	2019 Year 07 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 03 Day
Last modified on	2019 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042085