Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
42
Countries
1
Sites
1
not applicable (submitted trial is bioavailability)
Key facts
- Sponsor
- Pharma Start LLC
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 15 Sep 2025 → 9 Dec 2025
- Decision date (initial)
- 2025-08-28
- 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 bioavailability)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10047065 | Vascular disorders | 12 |
| 21.1 | PT | 10015488 | Essential hypertension | 100000004866 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pharma Start LLC
- Sponsor organisation
- Pharma Start LLC
- Address
- Bulv. Havela Vatslava 8
- City
- Kyiv
- Postcode
- 03124
- Country
- Ukraine
Scientific contact point
- Organisation
- Pharma Start LLC
- Contact name
- Anton Terentiev
Public contact point
- Organisation
- Pharma Start LLC
- Contact name
- Anton Terentiev
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 42 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2025-09-15 | 2025-12-09 | 2025-09-15 | 2025-09-27 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-25 | Czechia | Acceptable 2025-08-28
|
2025-08-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-01 | Czechia | Acceptable 2025-08-28
|
2025-09-01 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-02 | Czechia | Acceptable 2025-08-28
|
2025-12-02 |