A randomized, three-period, single-dose crossover trial in healthy female volunteers to demonstrate bioequivalence of tafoxiparin following subcutaneous administration via syringe/needle in the abdomen, and via an auto-injector in the abdomen and thigh, respectively.

Start 11 Feb 2026 · End 27 Mar 2026 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol PPL24

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Bioequivalence study

Status Ended

Participants planned 24

Countries 1

Sites 1

Labor priming

Sponsor: Dilafor AB
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Female
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Trial duration: 11 Feb 2026 → 27 Mar 2026
Decision date (initial): 2025-06-09
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

CTIS Part I — objectives, methods, condition coding

Labor priming

Sponsor organisations, regulatory contacts, third parties

1 EU/EEA country · 1 investigational sites

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

1 site · Ended

CTC Clinical Trial Consultants AB

CTC, Dag Hammarskjolds Vag 10b, Uppsala Domkyrkofors., Uppsala

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Sweden	2026-02-11	2026-03-27	2026-02-11	2026-03-05

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-04-02	Sweden	Acceptable 2025-06-09	2025-06-09