UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030017
Receipt number R000034277
Scientific Title Bioequivalence study of food
Date of disclosure of the study information 2017/11/19
Last modified on 2018/07/18 13:49:12

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Basic information

Public title

Bioequivalence study of food

Acronym

Bioequivalence study of food

Scientific Title

Bioequivalence study of food

Scientific Title:Acronym

Bioequivalence study of food

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the bioequivalence of foods.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cmax
AUC(0-24h)
iAUC(0-24h)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Single ingestion of test food.

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

Key inclusion criteria

(1)Males whose age are 20 <= years old <= 49.
(2)Subjects who are able to submit the written informed consents.

Key exclusion criteria

(1)Subjects who are with treatment.
(2)Subjects who are with history of gastrointestinal surgery.
(3)Subjects who are attending other studies or attended other studies within the past 4 weeks.
(4)Subjects who are;
(a)With present heart disorder, liver disorder, or kidney disorder,
(b)With history of cardiac disorder,
(c)With diabetes mellitus, or
(d)With allergy to the study foods.
(5)Subjects who are not negative for syphilis, HBs antigen, HCV antibody or HIV antigen/antibody test.
(6)Subjects who are deemed to be unsuitable by the investigator.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Nonaka

Organization

SUNTORY GLOBAL INNOVATION CENTER LIMITED

Division name

Research Institute

Zip code


Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

050-3182-0587

Email

Yuji_Nonaka@suntory.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Yamamoto

Organization

SUNTORY GLOBAL INNOVATION CENTER LIMITED

Division name

Research Institute

Zip code


Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

050-3182-0594

Homepage URL


Email

K_Yamamoto@suntory.co.jp


Sponsor or person

Institute

SUNTORY GLOBAL INNOVATION CENTER LIMITED

Institute

Department

Personal name



Funding Source

Organization

SUNTORY GLOBAL INNOVATION CENTER LIMITED

Organization

Division

Category of Funding Organization

Self funding

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

2017 Year 11 Month 19 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

2017 Year 11 Month 07 Day

Date of IRB


Anticipated trial start date

2017 Year 11 Month 20 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

2017 Year 11 Month 17 Day

Last modified on

2018 Year 07 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034277


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name