dit is een bioequivalentie onderzoek bioequivalence study
Conditions
Interventions
The subjects will be randomly allocated to receive five study products in a
pre-specified order on 5 different days:
2 times a dosage of UMP, 2 times a dosage of uridine and 1 time a placebo
Bioequivalence
Elderly
Uridine monophosphate
Sponsors
Nutricia Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age 60 years or older - BMI from 20 through 30 kg/m2 - Willingness and ability to comply with the protocol - Written informed consent
Exclusion criteria
Exclusion criteria: - 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) - Any gastrointestinal (GI) disease or surgery that interferes with GI function - (History of) any cancer with the exception of basal cell carcinoma - Any sign of inflammation in the last 7 days prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameters in this study are Urd AUC [µmol/L*min] and Cmax [µmol/L] (product B versus A). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome parameters in this study are Urd AUC [µmol/L*min] and Cmax [µmol/L] (product D vs. C), Tmax [min] and t* AUC [min] (product B vs A, D vs. C), Urd AUC [µmol/L*min], Cmax [µmol/L], Tmax [min] and t* AUC [min] (A vs. E, B vs. E, C vs. E, D vs. E). | — |
Countries
The Netherlands
Outcome results
None listed