Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
68
Countries
1
Sites
1
Type 1 Diabetes Mellitus
Key facts
- Sponsor
- Biocon Sdn. Bhd.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- completed 30 May 2024
- Decision date (initial)
- 2023-06-20
- 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
Type 1 Diabetes Mellitus
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Biocon Sdn. Bhd.
- Sponsor organisation
- Biocon Sdn. Bhd.
- Address
- No. 1 Jalan Bioteknologi 1, Kawasan Perindustrian Silc Kawasan Perindustrian Silc
- City
- Iskandar Puteri
- Postcode
- 79200
- Country
- Malaysia
Scientific contact point
- Organisation
- Biocon Sdn. Bhd.
- Contact name
- Sponsor’s Responsible Medical Monitor
Public contact point
- Organisation
- Biocon Sdn. Bhd.
- Contact name
- Sponsor's public contact point at Biocon Biologics Limited
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 68 | 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 | 2023-03-30 | Germany | Acceptable 2023-06-19
|
2023-06-20 |