Randomized, open-label, three-period crossover study on the palatability of oral dispersible formulations of Zonisamide in healthy volunteers.

2025-522297-36-00 Protocol DC03ZON/1/25 Human pharmacology (Phase I) - Other Ended

Start 3 Sep 2025 · End 6 Nov 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol DC03ZON/1/25

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 16
Countries 1
Sites 1

Healthy volunteers

Key facts

Sponsor
Noucor Health S.A.
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Not possible to specify
Trial duration
3 Sep 2025 → 6 Nov 2025
Decision date (initial)
2025-08-20
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Healthy volunteers

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Noucor Health S.A.

Sponsor organisation
Noucor Health S.A.
Address
Avinguda Del Cami Reial 51-57
City
Palau-Solita I Plegamans
Postcode
08184
Country
Spain

Scientific contact point

Organisation
Noucor Health S.A.
Contact name
Daniel Peris

Public contact point

Organisation
Noucor Health S.A.
Contact name
Daniel Peris

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ended 16 1
Rest of world 0

Investigational sites

Spain

1 site · Ended
Hospital Clinico San Carlos
Farmacologia Clinica, Calle Del Profesor Martin Lagos Sn, 28040, Madrid

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2025-09-03 2025-11-06 2025-09-08 2025-09-23

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-05-23 Spain Acceptable
2025-08-19
2025-08-20