Cargando…

Bioequivalence of Eslicarbazepine Acetate from Two Different Sources of its Active Product Ingredient in Healthy Subjects

PURPOSE: To compare the bioavailability (BA) and pharmacokinetic (PK) properties and to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL) in healthy volunteers. DESIGN, SUBJECTS AND METHODS: Forty healthy male and female subjects...

Descripción completa

Detalles Bibliográficos
Autores principales:	Falcão, Amílcar, Lima, Ricardo, Sousa, Rui, Nunes, Teresa, Soares-da-Silva, Patrício
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing AG 2013
Materias:	Original Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3689905/ https://www.ncbi.nlm.nih.gov/pubmed/23677811 http://dx.doi.org/10.1007/s40268-013-0016-6

Ejemplares similares

Comments on the Eslicarbazepine Acetate Section of the Article ‘Therapeutic Drug Monitoring of the Newer Anti-Epilepsy Medications’
por: Öztiryaki, Ahmet H., et al.
Publicado: (2010)

Eslicarbazepine acetate for the treatment of focal epilepsy: an update on its proposed mechanisms of action
por: Soares-da-Silva, Patrício, et al.
Publicado: (2015)

Exposure‐safety and efficacy response relationships and population pharmacokinetics of eslicarbazepine acetate
por: Gidal, B. E., et al.
Publicado: (2018)

Safety, Tolerability and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy in Patients Aged ≥ 65 Years with Focal Seizures
por: Costa, Raquel, et al.
Publicado: (2018)

Real‐world data on eslicarbazepine acetate as add‐on to antiepileptic monotherapy
por: Holtkamp, M., et al.
Publicado: (2016)

Eslicarbazepine acetate as adjunctive therapy in clinical practice: ESLADOBA study
por: Chaves, J., et al.
Publicado: (2017)

The pharmacokinetic, safety, and tolerability profiles of eslicarbazepine acetate are comparable between Korean and White subjects
por: Hwang, Sejung, et al.
Publicado: (2022)

Effects of eslicarbazepine acetate on acute and chronic latrunculin A-induced seizures and extracellular amino acid levels in the mouse hippocampus
por: Sierra-Paredes, Germán, et al.
Publicado: (2014)

Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension study
por: Trinka, Eugen, et al.
Publicado: (2020)

Eslicarbazepine acetate as adjunctive therapy in patients with uncontrolled partial-onset seizures: Results of a phase III, double-blind, randomized, placebo-controlled trial
por: Sperling, Michael R, et al.
Publicado: (2015)

Dibenzazepine Agents in Epilepsy: How Does Eslicarbazepine Acetate Differ?
por: Lawthom, Charlotte, et al.
Publicado: (2018)

Eslicarbazepine Acetate Modulates EEG Activity and Connectivity in Focal Epilepsy
por: Pellegrino, Giovanni, et al.
Publicado: (2018)

Update on the role of eslicarbazepine acetate in the treatment of partial-onset epilepsy
por: Tambucci, Renato, et al.
Publicado: (2016)

Antiepileptogenesis after stroke—trials and tribulations: Methodological challenges and recruitment results of a Phase II study with eslicarbazepine acetate
por: Koepp, Matthias J., et al.
Publicado: (2023)

Safety, Tolerability, and Pharmacokinetics of Etamicastat, a Novel Dopamine-β-Hydroxylase Inhibitor, in a Rising Multiple-Dose Study in Young Healthy Subjects
por: Nunes, Teresa, et al.
Publicado: (2012)

Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience
por: Gama, Helena, et al.
Publicado: (2017)

A Review of Eslicarbazepine Acetate for the Adjunctive Treatment of Partial-Onset Epilepsy
por: Singh, Rajinder P., et al.
Publicado: (2011)

Transition from oxcarbazepine to eslicarbazepine acetate: A single center study
por: Mäkinen, Jussi, et al.
Publicado: (2017)

Safety of Eslicarbazepine Acetate in Elderly Versus Non-Elderly Patients with Focal Seizures: From Pooled Data of Clinical Studies to 8 Years of Post-Marketing Experience
por: Magalhães, Luís M., et al.
Publicado: (2021)

Eslicarbazepine acetate in post‐stroke epilepsy: Clinical practice evidence from Euro‐Esli
por: Sales, Francisco, et al.
Publicado: (2020)

Eslicarbazepine acetate: its effectiveness as adjunctive therapy in clinical trials and open studies
por: Shorvon, S. D., et al.
Publicado: (2017)

Inhibitory Effect of Eslicarbazepine Acetate and S-Licarbazepine on Na(v)1.5 Channels
por: Leslie, Theresa K., et al.
Publicado: (2020)

Efficacy and tolerability of eslicarbazepine acetate as monotherapy in patients of newly diagnosed focal epilepsy
por: Saxena, S., et al.
Publicado: (2021)

Eslicarbazepine acetate is porphyrogenic and should be used with caution in patients with the acute hepatic porphyrias
por: Ma, Christopher D., et al.
Publicado: (2022)

Conversion to eslicarbazepine acetate monotherapy: A pooled analysis of 2 phase III studies
por: Sperling, Michael R., et al.
Publicado: (2016)

Development of a stress induced validated UPLC-PDA method for the analysis of Eslicarbazepine acetate
por: Iram, Farah, et al.
Publicado: (2018)

Psychiatric adverse events in three phase III trials of eslicarbazepine acetate for focal seizures
por: Altalib, Hamada, et al.
Publicado: (2022)

Association of Variability and Pharmacogenomics With Bioequivalence of Gefitinib in Healthy Male Subjects
por: Zhang, Hong, et al.
Publicado: (2018)

Bioequivalence of perampanel fine granules and tablets in healthy Japanese subjects
por: Shiba, Sari, et al.
Publicado: (2020)

Development and Validation of an RP-HPLC Method for Quantitative Estimation of Eslicarbazepine Acetate in Bulk Drug and Tablets
por: Singh, M., et al.
Publicado: (2013)

Adjunctive Treatment With Eslicarbazepine Acetate for Adults and Children With Focal-Onset Epilepsy: A Meta-Analysis
por: Fei, Yanqing, et al.
Publicado: (2022)

Evaluation of the Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Perampanel in Rats by Isotope-Dilution-UHPLC-MS/MS
por: Liu, Ping, et al.
Publicado: (2022)

Eslicarbazepine Acetate: A New Improvement on a Classic Drug Family for the Treatment of Partial-Onset Seizures
por: Galiana, Graciana L., et al.
Publicado: (2017)

Modeling and simulations to support dose selection for eslicarbazepine acetate therapy in pediatric patients with partial-onset seizures
por: Sunkaraneni, Soujanya, et al.
Publicado: (2018)

Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures
por: Mintz, Mark, et al.
Publicado: (2019)

Bioequivalence of the pharmacokinetics between tofacitinib aspartate and tofacitinib citrate in healthy subjects
por: Shin, Wonsuk, et al.
Publicado: (2020)

Bioequivalence of two oral formulations of tebipenem pivoxil hydrobromide in healthy subjects
por: Gupta, Vipul K., et al.
Publicado: (2022)

Pharmacokinetic and Bioequivalence Study of Eldecalcitol Soft Capsules in Healthy Chinese Subjects
por: Li, Ting, et al.
Publicado: (2022)

Pooled efficacy and safety of eslicarbazepine acetate as add‐on treatment in patients with focal‐onset seizures: Data from four double‐blind placebo‐controlled pivotal phase III clinical studies
por: Elger, Christian, et al.
Publicado: (2017)

Clinical utility of eslicarbazepine: current evidence
por: Zaccara, Gaetano, et al.
Publicado: (2015)

Cannot write session to /tmp/vufind_sessions/sess_u77g0aq1fm52i6n779duaot0lj