97 results
- To assess the effects of single and multiple daily doses of 50 mg JNJ-54861911 once daily (q.d.) on the pharmacokinetics of caffeine, midazolam, and tolbutamide in healthy male subjects. - To assess the safety and tolerability of the concomitant…
Part 1: To assess the safety, tolerability and pharmacokinetic-dynamic response, of single escalating doses of EA-230 in healthy subjects.Part 2: To assess the dose-and plasma concentration-response relation of single escalating doses EA-230 on…
Pharmacokinetic and pharmacodynamic properties of amlodipine oral liquid in the pediatric population
The primary objective of this study is to characterize the pharmacokinetic properties of amlodipine using the newly developed amlodipine oral solution 0.5 mg/ml in patients with chronic kidney diseases (CKD) and/or hypertension aged 6 months to…
To assess the long-term safety, efficacy, and pharmacokinetics of oral lubiprostone 12 or 24 mcg capsules dosed twice daily (BID) when administered orally for 36 weeks in paediatric subjects with functional constipation. Evaluation of lubiprostone…
To assess the efficacy, safety, and pharmacokinetics of oral lubiprostone 12 or 24 mcg capsules dosed twice daily (BID) (based on subject body weight at baseline) as compared to matching placebo BID, when administered orally for 12 weeks in…
Primary:1. To assess the pharmacokinetic profiles following single dose administration of MK-8408 administered as a PMF1 tablet by means of AUC0-*, AUClast, AUC0-24, Cmax, C24, tmax, and t* under fed conditions, following a high fat meal. 2. To…
The primary objective for part I of the study is the investigation of the pharmacokinetics. Although there is substantial clinical experience with all components of HTX-011, the formulation itself and the route of administration is new, which…
The primary aim of the trial is to assess what the optimal treatment regimen for acetylsalicylic acid, a statin and two BP-lowering agents is (administered as in regular care in individual agents, a fixed-dose combination pill administered in the…
The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed. The secondary objectives of…
Primary:* To demonstrate non-inferiority between the level of agreement in diagnosis (i.e. patient classification of normal, mild/moderate or severe ischemic disease based on the number of reversible perfusion segments) between sequential adenosine…
The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic…
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC (2.5/5 µg, 5/5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment.
The aim of this study is to assess and compare the pharmacokinetic parameters of the newly developed amlodipine besilate oral liquid 0,5 mg/ml with commercial Norvasc 5 mg tablets. The secondary objective is to assess the taste of the oral liquid.
The aim of the study is to measure whether there is a difference in LDL cholesterol levels or the 24 hour ambulatory blood pressure in individuals at high risk of cardiovascular disease when the polypill is taken in the morning compared with the…
The primary objectives of this study are: * To characterize the effects of 150 mg and 450 mg of AT1001 administered 2 hours before administration of agalsidase on the safety and plasma pharmacokinetics of agalsidase in subjects with Fabry Disease*…
The primary objective of this study is to evaluate the long-term safety and tolerability of the TAK-491CLD FDC in comparison to the OLM/HCTZ FDC in hypertensive subjects with moderate renal impairment.
Primary objective is to determine the plasma pharmacokinetics of ModraCape001 and compare these to the pharmacokinetic profile of Xeloda®.Secondary objectives are:• To determine the AUC in blood plasma of capecitabine and its metabolites 5-dFCR, 5-…
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 / 5 µg ; 5 / 5 µg) with tiotropium (5 µg), olodaterol (5 µg) and placebo on lung-hyperinflation and endurance time…
To evaluate PFS with XL184 treatment as compared with placebo in subjects with unresectable, locally advanced, or metastatic MTC to see if the investigational drug XL184 is effective in delaying the growth of the tumor.
The primary objective of this study is to quantitatively determine the pharmacokinetics (absorption, distribution, metabolism and excretion) of docetaxel (as ModraDoc003 10mg tablets) after administration of a single dose of oral docetaxel in…