23 results
The aim of the present study is to investigate the effectiveness of paracetamol as intravenous subscription form versus paracetamol as rectal subscription form in order to prevent pain in neonates. To study this, therapeutic doses, the doses…
Primary objective: to study the pharmacokinetics and pharmacodynamics of paracetamol intravenously in preterm infants with a gestational age of less than 32 weeks:Secondary objective(s): to study the safety and dose-effect relationship of…
The aim of this study is to test the hypothesis that intravenous acetaminophen will reduce morphine requirements in postoperative infants significantly (>30%).
1)to compare the analgesic efficacy of intravenous versus rectal paracetamol as assessed by VAS scores, PCA morphine consumption.2)To assess the pharmacokinetic profile of intravenous and rectal paracetamol by intravenous plasma paracetamol and…
The objective of the study is to investigate the plasma concentrations of paracetamol after an iv infusion using a model-derived infusion schedule.
Primary objective:• To evaluate the safety and tolerability of single intravenous (i.v.) doses of XAB05 in healthy subjects.Secondary objective:• To characterize the plasma pharmacokinetic (PK) profile of single i.v. doses of XAB05 in healthy…
Primary ObjectivesPart 1 * Single Ascending DoseThe primary objective of the single ascending dose (SAD) part of the study is to characterize the safety and tolerability of a single dose of PTC857 in healthy subjects.Part 2 * Multiple Ascending…
Part 1:Primary objective:• To estimate the relative bioavailability of two THB001 formulations in healthy adults.Secondary objectives:• To determine the single-dose pharmacokinetics (PK) of THB001•HCl salt and THB001 free base formulations in…
Primary: To compare the pharmacokinetics (PK) of the once daily (QD) and once weekly (QW) formulations of setmelanotideSecondary Objectives:To assess the safety of the QW formulation of setmelanotide with up to 6 months (26 weeks) of drug…
Primary objectives: • To determine the safety and tolerability of a single administration and single-day IDR of intravenous GH002.• To determine the pharmacokinetics (PK) of 5-MeO-DMT in healthy volunteers following a single administration and…
Primary objective:• To evaluate the safety and tolerability profile of single intravenous doses of AST-004 given as a short loading intravenous infusion followed by a 6-hour continuous intravenous (IV) infusion in healthy adult subjects.Secondary…
Primary objective:* To evaluate the safety of BYON5667 eye drops.Secondary objective:* To evaluate the tolerability of BYON5667 eye drops.
Part 1 SAD:Primary objective: To evaluate the safety and tolerability of single ascending doses of ANXV in healthy subjects.Secondary objective: To determine the PK profile of single ascending doses of ANXV in healthy subjects.Part 2 MAD:Primary…
Part 1:Primary objective:• To evaluate the PK profile of a single oral dose of ESB1609 jetmilled Form A in plasma and compare this profile with the PK profile of ESB1609 monohydrate Form B with 30% SLS.• To compare the PK profile of different…
* to evaluate the safety and tolerability of Lu AF90103 following single ascending intravenous (i.v.) doses* to investigate the pharmacokinetics (PK) of Lu AF90103 (prodrug) and Lu AF88361 (drug) in plasma and cerebrospinal fluid (CSF) following…
Primary objective: To evaluate the safety and tolerability of single ascending i.v. doses of OMN6 in healthy young and elderly adult subjects.Secondary objective: To evaluate OMN6 PK in plasma following single ascending i.v. doses in healthy young…
Primary objectives:To identify and quantify the excretion pathways of oral ASTX029, including the mass balance and the excretions in urine and feces (Period 1).To determine the absolute oral bioavailability (F) of ASTX029 under fasting conditions (…
Primary:1. To characterize the safety and tolerability of multiple oral doses of K-196 alone and in combination with naproxen/omeprazole in healthy subjects.Secondary:1. To assess the effects of K-196 compared to placebo on the proportion of…
Primary objective:• To investigate the effect of THB001 on the pharmacokinetics (PK) of caffeine, omeprazole and midazolam.Secondary objective:• To evaluate the safety and tolerability of THB001 co-administered with caffeine, omeprazole and…
Primary objective: - To evaluate the systemic absorption and pharmacokinetics of topically applied NT-077 Secondary objectives: - To evaluate the safety and tolerability of topically applied NT-077- To evaluate the pharmacodynamic effect on sweat…