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.

Start 20 Oct 2025 · End 19 Nov 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol ESP 301/BE

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Bioequivalence study

Status Ended

Participants planned 24

Countries 1

Sites 1

Bioequivalence study under fasting conditions

Key facts

Sponsor: Esperante Development B.V.
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Otorhinolaryngologic Diseases [C09]
Trial duration: 20 Oct 2025 → 19 Nov 2025
Decision date (initial): 2025-10-08
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Bioequivalence study under fasting conditions

Version	Level	Code	Term	System organ class
20.0	PT	10027183	Meniere's disease	100000004854

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Esperante Development B.V.

Sponsor organisation: Esperante Development B.V.
Address: Tolweg 15
City: Baarn
Postcode: 3741 LM
Country: Netherlands

Scientific contact point

Organisation: Esperante Development B.V.
Contact name: Esperante Development B.V.

Public contact point

Organisation: Esperante Development B.V.
Contact name: Esperante Development B.V.

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Czechia	Ended	24	1
Rest of world	—	0	—

Investigational sites

Czechia

1 site · Ended

Quinta-Analytica s.r.o.

Clinical Unit, Umelecka 305/1, Moravska Ostrava, Moravska Ostrava A Privoz

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Czechia	2025-10-20	2025-11-19	2025-10-20	2025-11-01

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-09-04	Czechia	Acceptable 2025-10-08	2025-10-08