4 results
Primary Objective: Validation of the Fresenius BCM in pediatric dialysis patients for the assessment of TBW and ECW using dilution techniques as the reference methods.Secondary Objective: Validation of saliva sampling for bromide concentration…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
Safety1) To evaluate the safety of implantation and use of the Closed Loop Medical SNS System for the duration of the device use.Performance2) Feasibility of using electrophysiological response recordings to guide targeting and stimulation delivery…