UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031610 |
|---|---|
| Receipt number | 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 21:01:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
itotk777@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036018
