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A Phase 1 Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of Bedtime Dosing of JZP-324 (Extended Release Oxybate) for Oral Suspension in Healthy Subjects

The purpose of this study is to investigate how quickly and to what extend JZP-324 is absorbed and eliminated from the body (this is called pharmacokinetics). It will also be investigated how safe the new compound JZP-324 is and how well it is…

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…

Predicting the success of mandibular repositioning appliance therapy in obstructive sleep apnea

the primary objective of our study is to define a set of patient characteristics that can predict the effectiveness of an MRA in treating symptomatic OSA. The aim of our study is to develop a prediction model to calculate the success rate in an…

An open-label, sequential study to assess the drug-drug interaction of divalproex sodium extended release (ER) at steady-state on FT218 formulation administered at a single 6-G evening dose in healthy male 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.…

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…

A randomized, double-blind, crossover taste testing study in healthy subjects comparing JZP-258 and placebo.

The purpose of this study is to compare the taste of JZP-258 to placebo (a medicine without any active ingredient or fake medicine) for sameness. This is to ensure that when used in other studies, subjects will not taste a difference between both…

An open label, sequential study to assess the drug-drug interaction of Divalproex Sodium extended release (ER) at steady-state on FT218 formulation administered at a single 6 g dose in healthy volunteeers

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 this…

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…

A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy

Primary ObjectiveThe primary objective of the study is:• To compare the efficacy of 6.0, 7.5, and 9.0 g of FT218 to placebo in treating EDS in both NT1 and NT2 subjects as measured by mean sleep latency on the Maintenance of Wakefulness Test (MWT)…

A Long-Term, Safety and Maintenance of Efficacy Study of JZP110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea

To evaluate the safety and tolerability of JZP-110 administered once daily for up to 52 weeks in doses of 75, 150, and 300 mg

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…

A Double-Blind, Placebo-Controlled, Randomized-Withdrawal,;Multicenter Study of the Efficacy and Safety of Xyrem with an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects with Narcolepsy with Cataplexy

Primary objectives are:1) To evaluate the efficacy of Xyrem (sodium oxybate) oral solution in the treatment of cataplexy in pediatric subjects with narcolepsy2) To evaluate the safety of Xyrem in the treatment of cataplexy in pediatric subjects with…

A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects with Narcolepsy with Cataplexy

Primary objective:To evaluate the efficacy of JZP-258 in the treatment of cataplexy in subjects with narcolepsyKey Secondary objective:To evaluate the efficacy of JZP-258 in the treatment of excessive daytime sleepiness (EDS) in…