Bioequivalence
Conditions
Interventions
After an overnight fast, subjects will ingest one dosage of one of the two study products at each study visit (except during screening).
Sponsors
Nutricia Research B.V., Utrecht, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: - Healthy volunteers - Age 60-80 years of age (both inclusive) - BMI from 20 through 30 kg/m2
Exclusion criteria
Exclusion criteria: - Any gastrointestinal (GI) disease or surgery that interferes with GI function - Known renal or hepatic failure - Known or suspected Diabetes Mellitus (fasting glucose level ¡Ý 7.0 mmol/L) - Fever (>38.5 oC) in the last 7 days prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameters in this study are amino acid AUC [ìmol/L*min] and Cmax [ìmol/L] | — |
Secondary
| Measure | Time frame |
|---|---|
| - Amino acid Tmax [min] and t½ AUC [min] - Glutamine, Essential amino acids and sum amino acids AUC [ìmol/L*min], Cmax [ìmol/L], Tmax [min] and t½ AUC [min] - Safety and GI tolerance parameters | — |
Contacts
Public ContactA. van Helvoort
Nutricia Research
Outcome results
None listed