Open label, single-center, cross-over randomized, relative bioavailability study comparing 4 new BF2.649 (pitolisant) tablet formulations versus the reference pitolisant (Wakix®) tablet formulation after single oral administrations in healthy male subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505769-98-00

Acronym

P22-06

Enrollment

Registered

2023-08-17

Start date

2023-09-26

Completion date

2024-01-03

Last updated

2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy, Narcolepsy with cataplexy

None listed

Sex/Gender

Male

Age

18 Years to 64 Years

Belgium

None listed

Source: EU CTIS · Data processed: Feb 4, 2026