Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
1
Healthy subjects
Key facts
- Sponsor
- Pevisal Group Farmaceutici S.r.l.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Decision date (initial)
- 2026-06-12
- 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
Healthy subjects
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10030970 | Oral contraception | 100000004865 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pevisal Group Farmaceutici S.r.l.
- Sponsor organisation
- Pevisal Group Farmaceutici S.r.l.
- Address
- Via Campania 13
- City
- Lecce
- Postcode
- 73100
- Country
- Italy
Scientific contact point
- Organisation
- Pevisal Group Farmaceutici S.r.l.
- Contact name
- Alessandro Allegrini
Public contact point
- Organisation
- Pevisal Group Farmaceutici S.r.l.
- Contact name
- Concetta Chirico
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-05-15 | Czechia | Acceptable 2026-06-11
|
2026-06-12 |