Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
54
Countries
1
Sites
1
Rheumatoid arthritis, ulcerative colitis, atopic dermatitis, Crohn's disease, psoriatic arthritis, axial spondyloarthritis
Key facts
- Sponsor
- Sun Pharmaceutical Industries Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 19 Aug 2024 → 12 Oct 2024
- Decision date (initial)
- 2024-07-15
- 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
Rheumatoid arthritis, ulcerative colitis, atopic dermatitis, Crohn's disease, psoriatic arthritis, axial spondyloarthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | LLT | 10003268 | Arthritis rheumatoid | 10028395 |
| 21.0 | LLT | 10037160 | Psoriatic arthritis | 10028395 |
| 20.0 | PT | 10011401 | Crohn's disease | 100000004856 |
| 21.1 | LLT | 10003639 | Atopic dermatitis | 10040785 |
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
| 21.1 | PT | 10071400 | Axial spondyloarthritis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sun Pharmaceutical Industries Limited
- Sponsor organisation
- Sun Pharmaceutical Industries Limited
- Address
- 1 Plot No 201 B, Western Express Highway, Goregaon East Western Express Highway Goregaon East
- City
- Mumbai
- Postcode
- 400063
- Country
- India
Scientific contact point
- Organisation
- Sun Pharmaceutical Industries Limited
- Contact name
- Arshad Khuroo
Public contact point
- Organisation
- Sun Pharmaceutical Industries Limited
- Contact name
- Arshad Khuroo
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ended | 54 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Terapia S.A.
Clinical Pharmacology and Pharmacokinetics, Strada Fabricii Nr 124, 400640, Cluj-Napoca
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 |
|---|---|---|---|---|---|
| Romania | 2024-08-19 | 2024-10-12 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-21 | Romania | Acceptable 2024-07-08
|
2024-07-15 |