8 results
Primary objective: To determine the pharmacokinetic profile of lopinavir and ritonavir in two differ-ent co-formulations (Lopimune granules and Lopimune tablets) after single-dose in HIV-negative, healthy adult subjects, and to compare this to the…
In this study we want to investigate whether the submission of zoledronic acid to neoadjuvant chemotherapy benefits the pathological complete response, and thus favors a better clinical outcome in patients with large ressectable or locally advanced…
Primary objective:- To evaluate dose modifications of the new Kaletra Meltrex tablets (lopi-navir/ritonavir 200/50 mg) when combined with rifampicin in healthy volunteersSecondary objectives:- To evaluate the safety of combined use of the new…
The first aim of the study is to investigate the effect of telaprevir on the concentration of LPV/rtv and ATV/rtv in the blood and the effect of LPV/rtv and of ATV/rtv the concentration of telaprevir in the blood.The second aim is to investigate the…
The purpose of the study is research. The study investigates to what extent ANF Rho is tolerated in comparison to Neulasta® (representing standard of care treatment) and placebo. A placebo is the same formulation as the study medication without the…
The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…
The purpose of the study is to compare LA-EP2006 and Neulasta®US and Neulasta®EU with respect to how quickly and to what extent the compounds are absorbed and eliminated from the body after injection under the skin of the abdomen (this is called…
To characterize the exposure-response relationship of MVT-602 effects on luteinizing hormone (LH) concentrations after subcutaneous administration of single 0.1 to 3 µg doses of MVT-602 or placebo in healthy premenopausal women undergoing COS to…