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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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520980-41-00
Acronym
P25-01
Enrollment
16
Registered
2025-03-06
Start date
2025-04-08
Completion date
2025-10-18
Last updated
2025-06-03

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

Conditions

Narcolepsy, narcolepsy with cataplexy

Interventions

None listed

Sponsors

Bioprojet Pharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Belgium

Outcome results

None listed

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