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…
- 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…
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…
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…
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…
- 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…
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…
To evaluate the safety and effectiveness of the ATS 3f Enable* Aortic Bioprosthesis equine pericardial stented bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures.
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.…
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,…
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…
Primary* To evaluate the effect of IW-6463 on cerebral blood flow (CBF) in healthy elderly participants* To assess the safety and tolerability of IW-6463 vs placebo when administered to healthy elderly participants for up to 15 daysExploratory* To…
Primary Objective:* To evaluate the effect of EDP-305 on alkaline phosphatase (ALP) levels.Secondary Objective:* To evaluate the safety and tolerability of EDP-305* To evaluate the effect of EDP-305 on bilirubin levels* To evaluate the effects of…
Primary* To evaluate the effect of EDP1066 in multiple formulations on the systemic immune system.Secondary* To evaluate the safety and tolerability of EDP1066 in multiple formulations.
Part 1Primary ObjectiveTo evaluate the local and systemic safety and tolerability of INM-755 cream following repeated once-daily topical applications for 14 days on healthy skin of healthy volunteersSecondary ObjectiveTo assess the local and…
* To evaluate the safety and tolerability of CyPep-1 when applied on healthy skin for up to one week. * To evaluate the safety and tolerability of CyPep-1 when applied to cutaneous warts for up to four weeks.* To evaluate the activity of the CyPep-1…
Primary Objective• To evaluate the local safety and tolerability of INM-755 cream following repeated once-daily topical applications for 14 consecutive days on wounded skin of healthy volunteers. Secondary Objectives• To evaluate the systemic safety…