An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with RINVOQ 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fasting condition.
Phase 1
- Conditions
- Rheumatoid arthritis, ulcerative colitis, atopic dermatitis, Crohn's disease, psoriatic arthritis, axial spondyloarthritisMedDRA version: 23.1Level: LLTClassification code: 10003268Term: Arthritis rheumatoid Class: 10028395MedDRA version: 21.0Level: LLTClassification code: 10037160Term: Psoriatic arthritis Class: 10028395MedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856MedDRA version: 21.1Level: LLTClassification code: 10003639Term: Atopic dermatitis Class: 10040785MedDRA version: 20.0Level: PTClassification code: 10009900Term: Colitis ulcerative Class: 100000004856MedDRA version: 21.1Level: PTClassification code: 10071400Term: Axial spondyloarthritis Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2024-512773-27-00
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 54
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