Bioequivalence
Conditions
Interventions
After an overnight fast, subjects will ingest one dosage of one of the five study products at each study visit (except during screening).
Sponsors
Nutricia Research B.V., Utrecht, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers 2. Age 60 years or older 3. BMI from 20 through 30 kg/m2
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameters in this study are Urd AUC [ìmol/L*min] and Cmax [ìmol/L] (product B versus A). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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]. | — |
Contacts
Public ContactA. van Helvoort
Nutricia Research
Outcome results
None listed