156 results
The purpose of the study is to investigate to what extent WCK 4282 is safe and tolerated. It will also be investigated how quickly and to what extent WCK 4282 is absorbed and eliminated from the body (this is called pharmacokinetics).
Primary: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulinglargine in HbA1c change from baseline to week 30.Secondary: To compare the overall efficacy and safety of insulin glargine/lixisenatide…
Primary ObjectivesPhase 1 portion:• to determine the maximum tolerable dose (MTD) of cytarabine (up to 2 g/m2/day x 5) that can be administered on Days 8-12 following treatment with DACOGEN 20 mg/m2/day on Days 1-5 of a 28 day cycle. • to determine…
To evaluate the safety and tolerability of ascending single and multiple oral doses of ADX71441 as compared to placebo in healthy volunteers.To evaluate the pharmacokinetics of orally administered single and multiple doses of ADX71441 and its…
CAEB071A2206 will assess safety, efficacy and target trough levels for optimal dosing of AEB071 combined with Certican in a CNI-free regimen in de novo renal transplant recipients. This study will combine the investigational drug AEB071 with an…
The primary objective of this study is to determine whether the pharmacokinetics of midazolam show circadian rhythmicity.
PRM-151 is being developed for potential therapeutic uses to prevent, treat, and reduce fibrosis. This study will provide an initial assessment of the safety, tolerability, and pharmacokinetics (PK) of PRM-151 after administration of ascending…
The primary objective is to determine the effect of co-administration of telepravir, given as 2 tablets of 375 mg every 8 hours and DRV/rtv or fAPV/rtv on the amount of telaprevir and DRV/rtv or fAPV/rtv in the body. The secondary objective is to…
Primary:The primary objective of this study is to evaluate the efficacy of LDX administered as a daily morning dose (30, 50, and 70mg/day) compared to placebo over the course of 7 weeks. This study will enrol children and adolescents (6-17 years of…
The goal of this trial is to confirm that eradication rates obtained with Pylera are compatible to those obtained with the current European gols standard, OAC 7 days. This trial will constitute a pivotal trial leading eventually to approval of…
We here propose a pilot immuno-PET study in active relapsing MS patients to investigate safety and sensitivity of 89Zr-rituximab in detecting CD20 positive (active) MS lesions and to assess inter-patient variability in 89Zr-rituximab biodistribition…
To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone.
To assess the bioequivalence of 6 mg dexamethasone tablet administered PO as an alternative to 5,26 mg dexamethasone-disodiumphosphate (= 4 mg dexamethasone) solution administered IV
The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times…
The primary objective is to characterize the change in the Pharmacodynamic (PD) biomarker, fecal calprotectin, during treatment with anrukinzumab.The secondary objectives include:* Characterization of the PK profile and total IL-13 of three multiple…
To assess the efficacy of Mirabegron 50mg versus Solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy.
To evaluate the safety of E2007 given as adjunctive, long-term treatment in patients with refractory partial onset seizures with or without secondary generalization that completed the E2007-A001-206 or the E2007-G000-208 studies (revised per…
To assess the effect of teriflunomide in comparison to placebo, on frequency of multiple sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with interferon beta (IFN-β)
Primary Objectives-To compare the efficacy responses of CP-690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP-690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16-week double-blind…
The objective of this study is to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% eye drops to those of tafluprost 0.0015% and timolol 0.5% eye drops given as individual…