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An open-label, randomized, crossover, phase 1 study to evaluate bioequivalence and relative bioavailability between JZP-507 commercial scale and pilot oral solutions in healthy subjects

During the study, an oral solution of JZP-507 produced on a commercial scale will be compared with a JZP-507 oral solution produced on a pilot scale (an oral solution of JZP-507 which is manufactured locally at PRA). The purpose of the study is to…

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.

Double-blind, placebo- and active-controlled, randomized, single-ascending dose study to investigate the tolerability, safety, pharmacokinetics, and pharmacodynamics of ACT-462206 in healthy male subjects

- To evaluate the safety and tolerability of ascending single oral doses of ACT-462206 in healthy male subjects.- To investigate the single oral dose PK and PD of ACT-462206 in healthy male subjects.- To investigate dose proportionality across…

Assessment of next-morning driving performance after middle of the night administration of zolpidem tartrate sublingual tablet 3.5 mg in healthy adult volunteers: single-center, double-blind, randomized, placebo-controlled, four-way crossover study

The aim of the study is to assess the risk of impaired driving in the morning at 3 and 4 hours after a middle-of-the-night dose of zolpidem tartrate sublingual tablet 3.5 mg.

A double-blind, randomized, placebo-controlled, double-dummy, four-way crossover study to investigate the drug-drug interactions of almorexant and ethanol in healthy subjects.

- To evaluate if co-administration of single-dose almorexant (200 mg) influences the psychomotor and cognitive impairing effects of ethanol (at a blood level of 0.6 g/L for 5 hours) in healthy subjects.-To evaluate the potential PK interactions…

A single-center, randomized, placebo-controlled, two-way crossover study to investigate the drug-drug interaction on the pharmacokinetics and pharmacodynamics of ACT-078573 and single-dose desipramine in healthy male subjects

Evaluation of the pharmacodynamic and pharmacokinetic effects of multiple doses of ACT-078573 on the pharmacokinetics of a single dose of desipramine

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

Primary Objectives:Part 1:To assess the relative bioavailability and bioequivalence of JZP-258 compared with Xyrem oral solution under fasting and fed conditions.To evaluate the pharmacokinetics (PK) of JZP-258 under fasting and fed conditions (food…

Study to evaluate the pharmacokinetics of oxybate formulations in healthy subjects.

The purpose of the study is to investigate how much JZP-258 is absorbed into the body, how fast JZP-258 is absorbed and eliminated from the body (this is called pharmacokinetics) compared to Xyrem. This comparison is called the relative…

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…

Single-center, randomized, double-blind, single-dose, 3-way crossover study to compare the effects of daridorexant and placebo on postural stability, the auditory awakening threshold, and cognitive function in the middle-of-the-night following evening administration to healthy adult and elderly subjects

To evaluate the pharmacodynamic (PD) effects of daridorexant 25mg, 50mg, and placebo in the middle-of-the-night.

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 Open-Label, Randomized, Crossover Pilot Study to Evaluate the Pharmacokinetics and Relative Bioavailability of JZP-324 Formulations vs. Xyrem in Healthy Subjects

Part 1:The purpose of the study is to compare 5 different JZP-324 formulations to Xyrem. It will be investigated how quickly and to what extent JZP-324 is absorbed and eliminated from the body (this is called pharmacokinetics) when compared to Xyrem…

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…

An open-label, randomized, crossover study to evaluate the pharmacokinetics, bioavailability, and bioequivalence following administration of JZP-507 oral solution and Xyrem®in healthy subjects.

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…