Comparative Bioavailability Study of New Pitolisant Hydrochloride Tablet Formulation Versus Marketed Pitolisant in Healthy Subjects

The primary objective of this study is to evaluate the **relative bioavailability** of a new **pitolisant hydrochloride** tablet formulation compared to the marketed pitolisant (Wakix®) tablet formulation. This is assessed after single oral administrations in healthy subjects. Understanding the bioavailability of the new formulation is clinically relevant as it may impact the therapeutic efficacy and safety profile of the drug in treating conditions such as **narcolepsy** and **narcolepsy with cataplexy**. The study is designed as an open-label, single-center, cross-over randomized trial, which allows for direct comparison of the two formulations in the same subjects, thereby minimizing inter-subject variability.

The clinical trial involves participants diagnosed with **narcolepsy**, including those with narcolepsy with cataplexy. The study population comprises both male and female subjects, with an age range that includes adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. Additionally, key inclusion or exclusion criteria have not been disclosed. The selection process for the trial population remains unspecified.

The clinical trial is designed as an **open-label**, single-center, cross-over randomized study to evaluate the relative bioavailability of a new **pitolisant hydrochloride** tablet formulation compared to the marketed pitolisant (Wakix®) tablet formulation. The trial will involve healthy subjects and is set to commence recruitment on April 1, 2025, with an estimated completion date of August 31, 2025. The study is categorized as a Phase 3 trial, focusing on the medical condition of **narcolepsy**, including narcolepsy with cataplexy.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, subjects will be randomized to receive either the new formulation or the marketed formulation in a cross-over manner. The trial will include multiple follow-up visits to monitor the pharmacokinetic parameters and safety profile of the formulations. The end-of-study visit will conclude the trial, where final assessments will be conducted to gather comprehensive data on the bioavailability of the formulations.

The expected duration of participant involvement will span the entire trial period, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include non-compliance with study procedures, adverse events that compromise participant safety, or withdrawal of consent. The trial's design ensures rigorous evaluation of the new formulation's bioavailability, contributing valuable data to the understanding of its pharmacological profile.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a paediatric formulation or if it is classified as an orphan drug. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the study may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available in the provided data.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on April 1, 2025, with an estimated completion date of August 31, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured methodology to measure, collect, and analyze these efficacy parameters, adhering to the standards expected in a Phase 3 clinical trial. The trial's design and execution will ensure that the efficacy assessments are conducted with scientific rigor and precision, although specific tools or instruments for these assessments are not mentioned in the available information.