4 results
PrimaryTo determine whether the palatability of a newly developed formulation of valacyclovir is non-inferior to administration of crushed and suspended tablets in children, is the primary objective of the second phase of the trial.The primary…
In this trial will be investigated if a new formulation of valacyclovir, e.g. oral solution, is bioequivalent to valacyclovir tablets. This comparison will be made by determining pharmacokinetic parameters (AUC0-*, Cmax, and tmax) of both…
The primary objective of this study is to assess the overall safety and tolerability of subcutaneous (SC) trastuzumab using SID (Singel Injection Device) in HER2-positive eBC (early Breast Cancer) patients self-administered at home under supervision…
To evaluate the efficacy of OT-101 Ophthalmic Solution in treating the progression of myopia in pediatric subjects following 3 years of treatment.To evaluate the safety and tolerability of OT-101 Ophthalmic Solution in pediatric subjects with myopia…