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A comparative, open-label, randomized, 2-stage sequential design, 2 periods, crossover study to demonstrate the bioequivalence of 2 FT218 batches (single dose of 4.5 gram) in healthy volunteers

The purpose of the study is to investigate how quickly and to what extent 2 different production batches of FT218 (batch A and batch B) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…

A multiple dose study to evaluate next day effects of MK-4305 on driving performance in healthy non-elderly subjects

The key objective of this study is to assess next-day residual effects of MK-4305 (20 and 40 mg) via driving performance after 1 day of dosing and after 8 days of dosing.

An open-label, randomized crossover pilot study to evaluate the pharmacokinetics, bioavailability, and bioequivalence following administration of Oxybate formulations in healthy subjects.

During the study, the 4 KEY-507 oral solutions (KEY-507-A, KEY-507-G, KEY-507-C, and KEY 507-D) will be investigated and compared to Xyrem. The purpose of the study is to investigate how quickly and to what extent KEY-507 oral solutions are absorbed…

A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects with Excessive Sleepiness Due to Narcolepsy

Primary objective:- To evaluate the effect of JZP-110 on driving performanceSecondary objectives:- To evaluate the safety and tolerability of JZP-110- To explore SAFTE (Sleep, Activity, Fatigue, and Task Effectiveness) modeling using driving,…

A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects with Excessive Sleepiness Due to Obstructive Sleep Apnea

Primary objective:- To evaluate the effect of JZP-110 on driving performanceSecondary objectives:- To evaluate the safety and tolerability of JZP-110- To explore SAFTE (Sleep, Activity, Fatigue, and Task Effectiveness) modeling using driving,…

An exploratory single-centre cross-over study in healthy subjects to investigate the effects of sleep deprivation on driving, EEG, and PainCart.

Part A• To assess the effect of sleep deprivation on next morning driving (both on road and in simulated driving) and subjective self-reported driving performance tests;• To assess the effect of sleep deprivation on CNS functioning using the…

An open label, randomized, 4 treatments, 4 periods, 4 sequence crossover study to assess the pharmacokinetics of four 6 g single-doses of once-nightly sodium oxybate (FT218) formulations with varying release rates in healthy volunteers

The purpose of this study is to investigate how quickly and to what extent 4 different formulations of FT218 are absorbed, distributed, metabolized and eliminated from the body.It will also be investigated how safe FT218 is and how well it is…

An exploratory, open-label, randomized, 2 treatments, 2 periods, 2 sequences crossover study to assess the pharmacokinetics of two FT218 batches (single dose administered at the dose of 6g) in healthy volunteers

FT218 is a new formulation of the drug sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid [GHB]), a registered drug under the tradename Xyrem® for the treatment of narcolepsy. FT218 has been administered to humans before.The…