dit is een bioequivalentie onderzoek bioequivalence study
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
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 60 - 80 years (both inclusive) - BMI from 20 through 30 kg/m2 - Willingness and ability to comply with the protocol - Written informed consent
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 >= 7.0 mmol/L) - (History of) any cancer with the exception of basal cell carcinoma - Fever (>38.5 C) 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 [µmol/L*min] and Cmax [µmol/L] | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome parameters in this study are: - Amino Acid Tmax [min] and t* AUC [min] - Glutamine, EAA and sum AA AUC [µmol/L*min], Cmax [µmol/L], Tmax [min] and t* AUC [min] - Safety and GI tolerance parameters | — |
Countries
Netherlands
Outcome results
None listed