Cargando…

Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT‐P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects

AIMS: To evaluate pharmacokinetic equivalence and preliminary safety of the adalimumab biosimilar CT‐P17 administered via autoinjector (CT‐P17 AI) or prefilled syringe (CT‐P17 PFS) in healthy subjects. METHODS: This phase I, open‐label study (ClinicalTrials.gov: NCT04295356) randomised subjects (1:1...

Descripción completa

Detalles Bibliográficos
Autores principales:	Davidson, Antonia, Brimhall, Darin, Kay, Jonathan, Keystone, Edward, Lee, Sang Joon, Kim, Sung Hyun, Bae, Yun Ju, Choi, Eun Jin, Furst, Daniel E.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2021
Materias:	Original Articles
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8597139/ https://www.ncbi.nlm.nih.gov/pubmed/33822406 http://dx.doi.org/10.1111/bcp.14850

Ejemplares similares

Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects
por: Shin, Donghoon, et al.
Publicado: (2018)

Pharmacokinetics of Subcutaneous Dupilumab Injection With an Autoinjector Device or Prefilled Syringe
por: Cohen, Yehuda Z., et al.
Publicado: (2022)

Pharmacokinetic and Pharmacodynamic Bioequivalence of Pegfilgrastim-cbqv Delivered via a Prefilled Autoinjector and Prefilled Syringe in Healthy Male Participants
por: Tang, Hong, et al.
Publicado: (2023)

GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its autoinjector device with prefilled syringes
por: von Richter, Oliver, et al.
Publicado: (2016)

Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies
por: Stauffer, Virginia L, et al.
Publicado: (2018)

A Pharmacokinetic Bioequivalence Study of Fremanezumab Administered Subcutaneously Using an Autoinjector and a Prefilled Syringe
por: Cherniakov, Irina, et al.
Publicado: (2021)

Comparison of drug delivery with autoinjector versus manual prefilled syringe and between three different autoinjector devices administered in pig thigh
por: Hill, Robert L, et al.
Publicado: (2016)

Similar Pharmacokinetics of the Adalimumab (Humira(®)) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE(®)-AI and VOLTAIRE(®)-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials
por: Ramael, Steven, et al.
Publicado: (2018)

Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects
por: Cox, Donna S., et al.
Publicado: (2021)

Comparable Pharmacokinetics, Safety, and Tolerability of Etrolizumab Administered by Prefilled Syringe or Autoinjector in a Randomized Trial in Healthy Volunteers
por: Zhang, Wenhui, et al.
Publicado: (2021)

Relative Bioavailability of a Single Dose of Belimumab Administered Subcutaneously by Prefilled Syringe or Autoinjector in Healthy Subjects
por: Struemper, Herbert, et al.
Publicado: (2015)

A Randomised Controlled Trial Comparing the Pharmacokinetics and Tolerability of the Proposed Adalimumab Biosimilar MSB11022 Delivered via Autoinjector and Pre-filled Syringe in Healthy Subjects
por: Sabet, Ahad, et al.
Publicado: (2022)

An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex(® )prefilled syringe in multiple sclerosis subjects
por: Phillips, J Theodore, et al.
Publicado: (2011)

Prefilled syringes: An innovation in parenteral packaging
por: Makwana, Sagar, et al.
Publicado: (2011)

Prefilled syringes for intravitreal drug delivery
por: Sassalos, Thérèse M, et al.
Publicado: (2019)

A Randomized Pharmacokinetic Study in Healthy Male Subjects Comparing a High-concentration, Citrate-free SB5 Formulation (40 mg/0.4 ml) and Prior SB5 (Adalimumab Biosimilar)
por: Ahn, So-shin, et al.
Publicado: (2022)

Prefilled syringes and usability of ophthalmic viscosurgical devices
por: Shiba, Takuya, et al.
Publicado: (2014)

Impact of Prefilled Syringes and Masking on Postintravitreal Injection Endophthalmitis
por: Louis, Abigail M., et al.
Publicado: (2023)

Randomized Crossover Comparison of Injection Site Pain with 40 mg/0.4 or 0.8 mL Formulations of Adalimumab in Patients with Rheumatoid Arthritis
por: Nash, Peter, et al.
Publicado: (2016)

Phase 3, open‐label, randomized study of the pharmacokinetics, efficacy and safety of ixekizumab following subcutaneous administration using a prefilled syringe or an autoinjector in patients with moderate‐to‐severe plaque psoriasis (UNCOVER‐A)
por: Callis Duffin, K., et al.
Publicado: (2016)

Spinal needle with prefilled syringe to prevent medication error: A proposal
por: Alam, Md Rabiul
Publicado: (2016)

Place of prefilled syringes in COVID-19 patient based on current evidence
por: Ludwin, Kobi, et al.
Publicado: (2021)

Subcutaneously administered methotrexate for rheumatoid arthritis, by prefilled syringes versus prefilled pens: patient preference and comparison of the self-injection experience
por: Demary, Winfried, et al.
Publicado: (2014)

Prefilled pen versus prefilled syringe: a pilot study evaluating two different methods of methotrexate subcutaneous injection in patients with JIA
por: Roszkiewicz, Justyna, et al.
Publicado: (2020)

Experience of unpleasant sensations in the mouth after injection of saline from prefilled syringes
por: Kongsgaard, Ulf E, et al.
Publicado: (2010)

Prefilled certolizumab pegol (Cimzia(®)) syringes for self-use in the treatment of rheumatoid arthritis
por: Rosa, J, et al.
Publicado: (2010)

Pharmacokinetic Profile of Subcutaneous Testosterone Enanthate Delivered via a Novel, Prefilled Single‐Use Autoinjector: A Phase II Study
por: Kaminetsky, Jed, et al.
Publicado: (2015)

Assessing usability, label comprehension, pen robustness and pharmacokinetics of a self-administered prefilled autoinjector pen of methotrexate in patients with rheumatoid arthritis
por: Pachon, Jaime A, et al.
Publicado: (2014)

Pharmacokinetic equivalence of CT‐P17 to high‐concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects
por: Yu, Kyung‐Sang, et al.
Publicado: (2021)

Magnocaine: Physical Compatibility and Chemical Stability of Magnesium Sulphate and Lidocaine Hydrochloride in Prefilled Syringes
por: Houlihan, Sara, et al.
Publicado: (2016)

Incidence of severe rise in intraocular pressure after intravitreous injection of aflibercept with prefilled syringes
por: Dingerkus, Vita Louisa Sophie, et al.
Publicado: (2022)

Science- and risk-based strategy to qualify prefillable autoclavable syringes as primary packaging material
por: Larmené-Beld, Karin, et al.
Publicado: (2022)

Are adrenaline autoinjectors fit for purpose? A pilot study of the mechanical and injection performance characteristics of a cartridge-versus a syringe-based autoinjector
por: Schwirtz, Andreas, et al.
Publicado: (2010)

Functional Evaluation and Characterization of a Newly Developed Silicone Oil-Free Prefillable Syringe System
por: Yoshino, Keisuke, et al.
Publicado: (2014)

Prefilled Cyclic Olefin Sterilized Syringes of Norepinephrine Injection Solution Do Not Need to Be Stabilized by Antioxidants
por: Larmené- Beld, Karin H. M., et al.
Publicado: (2020)

Utility of an educational video on epinephrine prefilled syringe usage for anaphylaxis: a randomized control trial
por: Yuenyongviwat, Araya, et al.
Publicado: (2020)

Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis
por: Fleischmann, Roy M., et al.
Publicado: (2022)

AVT02: An Adalimumab Biosimilar
por: Kang, Connie
Publicado: (2022)

Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis
por: Furst, Daniel E, et al.
Publicado: (2021)

Comparison of the Pharmacokinetics, Safety, and Tolerability of the Autoinjector (AI) and Pre-Filled Syringe (PFS) of SB4 in Healthy Subjects
por: Shin, Donghoon, et al.
Publicado: (2020)

Cannot write session to /tmp/vufind_sessions/sess_atvvbbhvhqknsmhj9d8oc7pp1v