- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02300740
Pharmacokinetic Analysis of Nicotinamide Riboside
February 26, 2015 updated by: Britt Christensen, Aarhus University Hospital
Nicotinamide riboside is a newly discovered vitamin B3.
The pharmacokinetics in humans is so far not analyzed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Medical Research Laboratories, Aarhus University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- BMI 18-25, healthy, male,
Exclusion Criteria:
- liver or kidney diseases, other diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: low dose
500 mg nicotinamide riboside oral
|
NIAGEN, ChromaDex
|
Experimental: high dose
1000 mg nicotinamide riboside oral
|
NIAGEN, ChromaDex
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum nicotinamide riboside
Time Frame: 8 hours, blood samples every 15 min
|
8 hours, blood samples every 15 min
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum concentrations of metabolites of nicotinamide riboside
Time Frame: 8 hour, blood samples every 15 min
|
8 hour, blood samples every 15 min
|
area under the curve for serum nicotinamide riboside
Time Frame: 8 hours, blood samples every 15 min
|
8 hours, blood samples every 15 min
|
calculation of halftime of serum nicotinamide riboside
Time Frame: 8 hours, blood samples every 15 min
|
8 hours, blood samples every 15 min
|
calculation of C-max of serum nicotinamide riboside
Time Frame: 8 hours, blood samples every 15 min
|
8 hours, blood samples every 15 min
|
calculation of t-max of serum nicotinamide riboside
Time Frame: 8 hours, blood samples every 15 min
|
8 hours, blood samples every 15 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
November 20, 2014
First Submitted That Met QC Criteria
November 21, 2014
First Posted (Estimate)
November 25, 2014
Study Record Updates
Last Update Posted (Estimate)
February 27, 2015
Last Update Submitted That Met QC Criteria
February 26, 2015
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 45141
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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