narcolepsy with cataplexy, Narcolepsy research hub
3 indexed studies · 0 currently recruiting
- ongoing, recruitingHuman Pharmacology (Phase I)- Other
Open label, single-center, cross-over randomized, relative bioavailability study comparing a new pitolisant hydrochloride tablet formulation versus the marketed pitolisant (Wakix®) tablet formulation after single oral administrations in healthy subjects.
This study is testing a new version of the existing medicine, pitolisant (Wakix®), which is used for narcolepsy. Researchers want to see if the new tablet works in the body similarly to the current one. Healthy adults will take both versions to compare them.
Belgium - ongoing, recruitingHuman Pharmacology (Phase I)- Other
Open label, single-center, four-part registration pharmacokinetic study: Part I: Pilot 2-way cross-over randomized, comparative pharmacokinetic study of a new gastro-resistant 20 mg pitolisant hydrochloride formulation versus the reference formulation, after a single 20 mg oral administration in twelve healthy subjects, in order to evaluate the adequate sample size to demonstrate the bioequivalence. Part II: One sequence cross-over, drug-drug interaction pharmacokinetic study between a proton pump inhibitor (PPI) (pantoprazole 40 mg) and a new gastro-resistant 20 mg pitolisant hydrochloride formulation in eighteen healthy subjects. Part III: Pivotal 4-way replicate design cross-over randomized, bioequivalence study of a new gastro-resistant 20 mg pitolisant hydrochloride formulation versus the reference formulation, after single oral 20 mg administration in healthy subjects. Part IV: 2-way cross-over randomized, food effect study of a new gastro-resistant 20 mg pitolisant hydrochloride formulation administered under fasting conditions and after a standard FDA High Fat Breakfast in eighteen healthy subjects.
This study looks at a new way to give a medicine called pitolisant. It checks how the body handles this new medicine compared to the old one, how it interacts with another common stomach medicine, and if food affects it. It's for healthy volunteers.
Belgium - ongoing, recruitingHuman Pharmacology (Phase I)- Other
Randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of pitolisant after repeated oral ascending doses for 14 days, including the pitolisant effect on cardiac repolarization in healthy volunteers.
This study is looking at a new medicine called pitolisant for narcolepsy, a condition that makes you very sleepy. We want to see if it's safe to take in different doses and how it affects the body over 14 days in healthy men.
Belgium