Contrast enhancement in magnetic resonance imaging in children
Conditions
Brief summary
Area under the curve (AUC) of gadoquatrane after single administration, Plasma clearance normalized to body weight (CL/BW) of gadoquatrane after single administration, Apparent volume of distribution at steady state normalized to body weight (Vss/bw), Simulation of plasma concentration at 20 minutes post-injection (C20)
Detailed description
Number and intensity of treatment-emergent AEs (TEAEs), including number of SAEs, occurring within 24 (±4) hours post-injection or in the post-treatment period of 7 (±1) days after the day of study intervention
Interventions
DRUGBAY 1747846
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) of gadoquatrane after single administration, Plasma clearance normalized to body weight (CL/BW) of gadoquatrane after single administration, Apparent volume of distribution at steady state normalized to body weight (Vss/bw), Simulation of plasma concentration at 20 minutes post-injection (C20) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and intensity of treatment-emergent AEs (TEAEs), including number of SAEs, occurring within 24 (±4) hours post-injection or in the post-treatment period of 7 (±1) days after the day of study intervention | — |
Countries
Bulgaria, Czechia, Germany, Hungary, Italy, Poland, Sweden
Outcome results
None listed