3 results
Approved WMOCompleted
Primary:To evaluate the effects of 15 mg E4/3 mg DRSP, of 30 mcg EE/150 mcg LNG, and of 20 mcg EE/3 mg DRSP on hemostasis, endocrine function and lipid and carbohydrate metabolism parameters during 6 treatment cycles.Secondary:To assess the safety…
Approved WMOCompleted
To demonstrate a 25% increase of docetaxel in tumor tissue after intravenous with CriPec® docetaxel compared to Taxotere®. Additionally, systemic PK profile and adverse events will also be evaluated.
Approved WMOCompleted
Validation of the Eleveld PKPD model, both the pharmacokinetic component (plasma concentrations) and the pharmacodynamic component (effect: bispectral index (BIS) and predicted effect-site concentrations).