9 results
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
The main objectives of this study are to evaluate the safety and performance of the AutoLap system in the following laparoscopic procedures: hernia repair, cholecystectomy, right colectomy, Nissen fundoplication and sigmoidresection. The AutoLap…
The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections (right hemicolectomy, left hemicolectomy/sigmoid resection), anti-reflux/hiatal hernia…
Primary Objective:- To assess the efficacy of escalating doses of ANF-RHO versus Neulasta in the duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] * 2.0 x 109/L) in the first chemotherapy cycle (21-day cycle FE100C).Secondary…
Part 1:The purpose of Part 1 of the study is to investigate how much of the OZ439 compound is absorbed into, distributed in, and eliminated from the body (this is called pharmacokinetics) when administered orally as compared to an intravenous (iv;…
- 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…
The aim of this study is to investigate the use of cobicistat to reduce the required dose and dose frequency of tofacitinib in the treatment of RA.
Part APrimary objective1. To determine the equivalence of the Area-Under-the-Curve (AUC) of the reduced, boosted dose of olaparib and the regular dose.Secondary objectives1. To determine whether boosting reduces the inter- and intrapatient PK…
The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is enhanced when osimertinib is co-administered with cobicistat in patients with relatively low blood concentrations while receiving the standard…