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UMIN-CTR Clinical Trial |
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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 |
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 |
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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 |
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Region |
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Condition | |||
Condition | Not applicable | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 8 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |