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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031610
Receipt No. R000036018
Scientific Title Pharmacokinetics of orally-administered Nicotinamide Powder 10% Zonne and its NAD+ pathway metabolites
Date of disclosure of the study information 2018/03/06
Last modified on 2019/05/22

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Basic information
Public title Pharmacokinetics of orally-administered Nicotinamide Powder 10% Zonne and its NAD+ pathway metabolites
Acronym Pharmacokinetics of vitamin B3 and NAD+ metabolites
in blood and urine
Scientific Title Pharmacokinetics of orally-administered Nicotinamide Powder 10% Zonne and its NAD+ pathway metabolites
Scientific Title:Acronym Pharmacokinetics of vitamin B3 and NAD+ metabolites
in blood and urine
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure the concentration of nicotinamide and NAD+ pathway metabolites after oral administration of Nicotineamide Powder 10% Zonne
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Pharmacokinetics of NAD+ in the blood and urine following the single administration of the drug
Key secondary outcomes Pharmacokinetics of nicotinamide in the blood and urine following the single administration of the drug

Safety evaluation with liver function monitoring

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 A single oral administration of Nicotinamide Powder 10% Zonne containing 200 mg of nicotinamide
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Those who agree to sign the informed consent form.
Key exclusion criteria 1. Those who take supplements containing vitamin B3 and wish to continue during the trial.
2. Those who are potentially pregnant.
3. Those who are under lactation.
4. Those who are under treatment.
5. Those judged by doctors or researchers to be inappropriate to participation in research.
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsutoshi Setou
Organization Hamamatsu University School of Medicine
Division name Department of Cellular and Molecular Anatomy
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192 Japan
TEL 053-435-2086
Email setou@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Ito
Organization Hamamatsu University School of Medicine
Division name Department of Cellular and Molecular Anatomy
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192 Japan
TEL 053-435-2086
Homepage URL
Email itotk777@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 03 Month 06 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 03 Month 01 Day
Date of IRB
2018 Year 01 Month 12 Day
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 06 Day
Last modified on
2019 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036018

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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