No registrations found.
ID
Source
Brief title
Health condition
Bioequivalence
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameters in this study are Urd AUC [ìmol/L*min] and Cmax [ìmol/L] (product B versus A).
Secondary outcome
The secondary outcome parameters in this study are Urd AUC [ìmol/L*min] and Cmax [ìmol/L], Tmax [min] and t½ AUC [min] , Urd AUC [ìmol/L*min], Cmax [ìmol/L], Tmax [min] and t½ AUC [min].
Background summary
Background of the study:
In this study it will be investigated whether equimolar dosages of a nucleotide and an alternative ingredient will produce bioequivalent Urd plasma levels.
In this study healthy older adults are requested to consume 5 different study products. Each subject will visit the site 5 times and at every visit they will consume 1 of the 5 products after which a series of blood samples will be taken.
Study objective
To investigate whether uridine (Urd) area under the curve (AUC) and Cmax of product B is equivalent to the Urd AUC and Cmax of product A
Study design
Time points of the outcome: Study visit 1-5
Intervention
After an overnight fast, subjects will ingest one dosage of one of the five study products at each study visit (except during screening).
A. van Helvoort
PO Box 80141
Utrecht 3508 TC
The Netherlands
Tel. +31-30-2095000
Email: A.vanHelvoort@nutricia.com
A. van Helvoort
PO Box 80141
Utrecht 3508 TC
The Netherlands
Tel. +31-30-2095000
Email: A.vanHelvoort@nutricia.com
Inclusion criteria
1. Healthy volunteers
2. Age 60 years or older
3. BMI from 20 through 30 kg/m2
Exclusion criteria
1. Any condition that may interfere with the definition ‘healthy volunteer’ according to the investigator, with special attention to the presence of liver and renal disease, diabetes mellitus, Alzheimer, diarrhea, obstipation and known severe weight loss (> 3 kg in last 3 months)
2. Any gastrointestinal (GI) disease or surgery that interferes with GI function
3. (History of) any cancer with the exception of basal cell carcinoma
4. Any sign of inflammation in the last 7 days prior to Visit 1
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5149 |
| NTR-old | NTR5289 |
| Other | Nutricia Research : Alz.1.P/E |