UMIN-CTR Clinical Trial

Basic information
Public title	Measurement of plasma acetaldehyde by a new method for single intake of alcoholic beverages in healthy adults
Acronym	Study on new measurement method of plasma acetaldehyde
Scientific Title	Measurement of plasma acetaldehyde by a new method for single intake of alcoholic beverages in healthy adults
Scientific Title:Acronym	Study on new measurement method of plasma acetaldehyde
Region	Japan

Condition
Condition	healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate measurements of plasma acetaldehyde concentrations
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate measurements of plasma acetaldehyde concentrations
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	55 years-old >=
Gender	Male and Female
Key inclusion criteria	1. BMI 18.5<= , <30.0 kg/m2 2. No abnormal findings in physical examination 3. Giving written informed conset
Key exclusion criteria	1. Having allergy for alcohol and/or intolerance for alcohol 2. Having any disease that needs to be treated 3. Having history of any severe allergy 4. Having history of any drug abuse and/or alcohol abuse
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Naoyuki Middle name Last name Otani
Organization	Oita University Faculty of Medicine
Division name	Clinical Pharmacology and Therapeutics
Zip code	879-5593
Address	1-1 Idaigaoka, Hasama-town, Yufu-city, Oita
TEL	097-586-5952
Email	naoyuki@oita-u.ac.jp

Public contact
Name of contact person	1st name Naoyuki Middle name Last name Otani
Organization	Oita University Faculty of Medicine
Division name	Clinical Pharmacology and Therapeutics
Zip code	879-5593
Address	1-1 Idaigaoka, Hasama-town, Yufu-city, Oita
TEL	097-586-5952
Homepage URL
Email	naoyuki@oita-u.ac.jp

Sponsor
Institute	Oita Unversity Faculty of Medicine
Institute
Department

Funding Source
Organization	Department of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University
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	Oita University Faculty of Medicine Ethics Committee
Address	1-1 Hasama-machi, Yufu-City Oita
Tel	097-586-5120
Email	syomu@oita-u.ac.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 05 Month 13 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	2019 Year 03 Month 27 Day
Date of IRB	2019 Year 03 Month 15 Day
Anticipated trial start date	2019 Year 05 Month 14 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	1. Take 500 ml beer for 30min. 2. Collecting blood, breath, and saliva 3 times each when before taking beer, after one hour and after four hours.

Management information
Registered date	2019 Year 05 Month 12 Day
Last modified on	2022 Year 05 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041836