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
ID
Bron
Verkorte titel
Aandoening
Bioequivalence
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome parameters in this study are Urd AUC [ìmol/L*min] and Cmax [ìmol/L] (product B versus A).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
Time points of the outcome: Study visit 1-5
Onderzoeksproduct en/of interventie
After an overnight fast, subjects will ingest one dosage of one of the five study products at each study visit (except during screening).
Publiek
A. van Helvoort
PO Box 80141
Utrecht 3508 TC
The Netherlands
Tel. +31-30-2095000
Email: A.vanHelvoort@nutricia.com
Wetenschappelijk
A. van Helvoort
PO Box 80141
Utrecht 3508 TC
The Netherlands
Tel. +31-30-2095000
Email: A.vanHelvoort@nutricia.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Healthy volunteers
2. Age 60 years or older
3. BMI from 20 through 30 kg/m2
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5149 |
| NTR-old | NTR5289 |
| Ander register | Nutricia Research : Alz.1.P/E |