Open-label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, study to assess the bioequivalence between the test product Betahistine dihydrochloride 24 mg tablets from Esperante Development BV and reference product Betaserc® 24 mg tablets.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522971-27-00

Acronym

ESP 301/BE

Enrollment

Registered

2025-10-08

Start date

2025-10-20

Completion date

2025-11-19

Last updated

2025-10-08

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

Conditions

Bioequivalence study under fasting conditions

None listed

Sex/Gender

All

Age

18 Years to 64 Years

Czechia

None listed

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