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Similar Pharmacokinetics of the Adalimumab (Humira
- Source :
- Rheumatology and Therapy
- Publication Year :
- 2018
-
Abstract
- Introduction BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira®. We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity of BI 695501 delivered via autoinjector (AI) vs. prefilled syringe (PFS). Methods Both trials were randomized, open-label, parallel-group studies undertaken in subjects aged ≥ 18–65 years. VOLTAIRE®-AI (NCT02606903) recruited healthy, Caucasian, male, non-athletic volunteers with BMI ≥ 18 to ≤ 30 kg/m2. VOLTAIRE®-TAI (NCT02899338) recruited healthy men and women with BMI > 17.5 to
- Subjects :
- Autoinjector
BI 695501
Biosimilar
Prefilled syringe
Adalimumab
Original Research
Subjects
Details
- ISSN :
- 21986576
- Volume :
- 5
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Rheumatology and therapy
- Accession number :
- edsair.pmid..........7592e489a89bd9d22ef4e952d2009d3c