11 results
The objectives are:1. the effect of steady state concentrations of voriconazole and fluconazole on the steady-state pharmacokinetics of TMC125,2. the effect of steady-state concentrations of TMC125 on the steady-state pharmacokinetics of…
Are fluconazole saliva levels representative for serum levels in children and neonates?
Primary objective: To determine the effect of obesity (BMI *35 kg/m2) on the pharmacokinetics, including oral bioavailability of fluconazole.Secondary objective: To develop an optimal dosing regimen for obese patients.
Primary objective: To evaluate the efficacy of GWP42003-P as adjunctive treatment inreducing the number of drop seizures when compared with placebo, inpatients with LGS.Drop seizure is defined as an attack or spell (atonic, tonic or tonic-clonic)…
Primary Objective: To determine whether GWP42003-P affects the pharmacokinetic (PK) profile of stiripentol (STP) or valproate (VPA).Secondary Objective: To assess the safety and tolerability of GWP42003-P in the presence of STP or VPA.To assess…
Primary ObjectiveTo determine whether GWP42003-P affects the pharmacokinetic (PK) profile of stiripentol (STP) or valproate (VPA).Secondary Objective(s)To assess the safety and tolerability of GWP42003-P in the presence of STP or VPA.
To evaluate the long term safety and tolerability of GWP42003-P, as adjunctive treatment, in children and adults with inadequately controlled DS or LGS.All Patients:To evaluate the effect of GWP42003-P, as adjunctive treatment, on:* Quality of life…
To assess the efficacy of GWP42003-P as an adjunctive antiepileptic treatment compared with placebo, with respect to the percentage change from baseline during the treatment period of the study in convulsive seizure frequency. The dose response…
Primary Objective Blinded Phase:• To evaluate the efficacy of GWP42003-P as add-on therapy in reducing the frequency of seizures when compared with placebo in patients with TSC.Open-label Extension:• To evaluate via the adverse events (AE) profile…
4.1 Primary Objective• To determine the MTD and to establish the safety profile of enapotamab vedotin in a mixed population of patients with specified solid tumors. 4.2 Secondary Objectives• To evaluate the safety laboratory parameters of enapotamab…
Primary objective:• To establish an improved fluconazole dosing regimen for paediatric and adolescent patients aged 2-18 years. Exploratory objectives:• To explore the role of renal function on the clearance of fluconazole.• To explore the…