Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
36
Countries
1
Sites
1
Hypercholesterolemia
Key facts
- Sponsor
- Laboratorios Alter S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 23 Feb 2026 → 6 Apr 2026
- Decision date (initial)
- 2026-02-17
- 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
Hypercholesterolemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10058108 | Dyslipidaemia | 100000004861 |
| 20.0 | SOC | 10027433 | Metabolism and nutrition disorders | 6 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Laboratorios Alter S.A.
- Sponsor organisation
- Laboratorios Alter S.A.
- Address
- Calle De Mateo Inurria 30
- City
- Madrid
- Postcode
- 28036
- Country
- Spain
Scientific contact point
- Organisation
- Laboratorios Alter S.A.
- Contact name
- Carmen Morillo Alonso
Public contact point
- Organisation
- Laboratorios Alter S.A.
- Contact name
- Carmen Morillo Alonso
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 36 | 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 |
|---|---|---|---|---|---|
| Spain | 2026-02-23 | 2026-04-06 | 2026-02-24 | 2026-03-10 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-05 | Spain | Acceptable 2026-02-13
|
2026-02-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-05 | Spain | Acceptable 2026-02-13
|
2026-03-05 |