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AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, TWO-STAGE CROSSOVER ADAPTIVE BIOEQUIVALENCE STUDY OF TRIAMCINOLONE ACETONIDE 40 MG/ML STERILE INJECTABLE SUSPENSION (Test product–Lisapharma S.p.A) VERSUS KENACORT® 40 MG/ML SUSPENSION (Reference product – Bristol Myers Squibb) AFTER INTRAMUSCULAR ADMINISTRATION TO HEALTHY VOLUNTEERS

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509399-40-00
Enrollment
30
Registered
2024-04-04
Start date
2024-05-09
Completion date
2025-03-27
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dermatoses, generalized rheumatoid arthritis and other connective tissue diseases., Intramuscular administration of triamcinolone acetonide Lisapharma (Injectable suspension of triamcinolone acetonide) is indicated for systemic corticosteroid therapy in morbid conditions such as allergic syndrome (to control severe or debilitating conditions not treatable in a conventional way)

Interventions

None listed

Sponsors

Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026