58 results
Primary Objective: - to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two…
Primary ObjectiveTo evaluate and compare the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites MK-5172, and MK-8742 following administration of three test premarket…
4.1 Primary• To estimate the Sensitivity and False Positive rate of OTL38 for malignancy detection during Near Infrared Imaging (NIR).• To assess the safety and tolerability of single intravenous doses of OTL384.2 Secondary• To assess the safety of…
Primary objective:* To compare the bioavailability of different dry powder formulations of tiotropium bromide in healthy volunteersSecondary objectives:* To compare the safety and tolerability of different dry powder formulations of tiotropium…
To investigate the potential influence of time of dosing (morning or evening)on the bronchodilator effect of once daily orally inhaled QVM149 compared toplacebo.
FT218 is a new formulation (composition) of the registered drug sodium oxybate. Sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid [GHB]) is registered under the name Xyrem® for the treatment of narcolepsy. The purpose of…
- To evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-*, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixed-dose combinations…
Will spinal anaesthesia with sufentanil and bupivacaine heavy cause less hypotension compared to bupivacaine heavy alone? Will there be less use of ephedrine/fenylefrine/noradrenaline if sufentanil is added to bupivacaine heavy for spinal…
Primary objective- To determine safety and tolerability of a single dose of cRGD-ZW800-1 in healthy volunteers.Secondary objectives- To determine the pharmacokinetics of a single dose of cRGD-ZW800-1 by measuring the fluorescence of blood and urine…
The purpose of the study is to investigate how quickly and to what extent JZP-507 is absorbed and eliminated from the body (this is called pharmacokinetics). This will be compared to the pharmacokinetics of Xyrem®. If the results show that the…
Benepali® and Brenzys® are approved as drugs that are administered as a subcutaneous (under the skin) injection using a pre-filled syringe. With a pre-filled syringe the drug is delivered through a needle which is inserted manually into the skin.…
- to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-*, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixeddose combination…
The primary purpose of the study is to investigate how quickly and to what extent traces of metals that are naturally present in Smecta® could be absorbed and eliminated from the body (this is called pharmacokinetics). For exploratory purposes, the…
* The primary objective is to assess the safety and tolerability of single and multiple intravenous doses of Minocin IV when administered to healthy adult subjects.* The secondary objective is to assess the pharmacokinetics of single and multiple…
Primary objective: To investigate the pharmacokinetics (PK) of multiple doses arimoclomol in plasma en urine.To investigate and quantify metabolites of arimoclomol in plasma and urine (reported seperately)Secondary objective: To evaluate the safety…
Primary objectiveTo evaluate if tralokinumab after 14 weeks of treatment (at steady state) changes the metabolism of substrates of CYP 1A2, 2C9, 2C19, 2D6, or 3A4 pathways in subjects with moderate-tosevere atopic dermatitisSecondary objectivesTo…
Primary objectivesPart 1To evaluate the single dose safety and tolerability of donepezil 10 mg when administered with placebo, glycopyrrolate or trospiumPart 2To evaluate the safety and tolerability of donepezil when given with concomitant placebo,…
Primary Objective- To determine safety and tolerability of a single dose of ZW800-1 in healthy volunteers.Secondary Objectives- To determine the pharmacokinetics of a single dose of ZW800-1 by measuring the fluorescence of blood and urine.- To…
Primary objective:- To evaluate safety and tolerability of LRX712 after a single i.a. injection in OA patients.Secondary objective: - To evaluate LRX712 and metabolite MAE344 pharmacokinetics in plasma.Exploratory objectives:- To evaluate LRX712 and…
The purpose of this study is to investigate how safe the new compound JHL1922 is when it is administered to healthy subjects. JHL1922 has not been administered to humans before, but it has been previously tested in the laboratory. In this study, the…