Search for a trial

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…

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…

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…

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 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…