The pilot bioavailability study comparing the absorption of carbetocin (which is used as prevention of heavy bleeding after childbirth) in PABAL 100 μg/mL Solution for Injection when administered sublingually in the dose of 500 μg and intramuscularly in the dose of 100 μg.

Start 13 Mar 2026 · End 25 Mar 2026 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol 1067/25

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Bioequivalence study

Status Ended

Participants planned 4

Countries 1

Sites 1

Not applicable (submitted trial is a bioavalability study in healthy participants).

Key facts

Sponsor: Oxytone Bioscience B.V.
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Female
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Trial duration: 13 Mar 2026 → 25 Mar 2026
Decision date (initial): 2026-02-09
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

Not applicable (submitted trial is a bioavalability study in healthy participants).

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oxytone Bioscience B.V.

Sponsor organisation: Oxytone Bioscience B.V.
Address: Hoofdstraat 43
City: Schijndel
Postcode: 5481 AA
Country: Netherlands

Scientific contact point

Organisation: Oxytone Bioscience B.V.
Contact name: Yvone van Rijswick

Public contact point

Organisation: Oxytone Bioscience B.V.
Contact name: Yvone van Rijswick

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Czechia	Ended	4	1
Rest of world	—	0	—

Investigational sites

Czechia

1 site · Ended

Quinta-Analytica s.r.o.

Clinic, 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	2026-03-13	2026-03-25	2026-03-13	2026-03-19

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-12-10	Czechia	Acceptable 2026-01-21	2026-02-09
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2026-02-13	Czechia	Acceptable 2026-01-21	2026-02-13
3	NON SUBSTANTIAL MODIFICATION	NSM-2	2026-03-03	Czechia	Acceptable 2026-01-21	2026-03-03