Hypolactasia
Conditions
Brief summary
PK analysis for urinary xylose excretion will be based on the following parameters: maximum urinary excretion rate detected at 0-3, 3-4 and 4-5h; its mean time during the corresponding interval (Tmax) and total xylose excreted (Ae0-5). All urine samples will be analyzed at a laboratory located in Hospital Universitario de Getafe
Detailed description
The incidence of adverse events (AEs), as well as relevant and abnormal changes from baseline in laboratory test results, and changes to vital signs in the treatment arm compared to the control arm.
Interventions
Sponsors
Venter Pharma S.L.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK analysis for urinary xylose excretion will be based on the following parameters: maximum urinary excretion rate detected at 0-3, 3-4 and 4-5h; its mean time during the corresponding interval (Tmax) and total xylose excreted (Ae0-5). All urine samples will be analyzed at a laboratory located in Hospital Universitario de Getafe | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events (AEs), as well as relevant and abnormal changes from baseline in laboratory test results, and changes to vital signs in the treatment arm compared to the control arm. | — |
Countries
Spain
Outcome results
None listed