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
Phase 1
- Conditions
- 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), dermatoses, generalized rheumatoid arthritis and other connective tissue diseases.Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2023-509399-40-00
- Lead Sponsor
- aboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method