9 results
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…
* 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…
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 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…
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…
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 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…