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Bioequivalence of a biosimilar enoxaparin sodium to Clexane(®) after single 100 mg subcutaneous dose: results of a randomized, double-blind, crossover study in healthy volunteers

PURPOSE: To demonstrate the pharmacokinetic/pharmacodynamic (PK/PD) equivalence of a biosimilar enoxaparin to the reference drug, and to assess its safety and tolerability in healthy volunteers. PATIENTS AND METHODS: A randomized, double-blind, crossover, 2-sequence, single-dose study was conducted...

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Detalles Bibliográficos
Autores principales: Martínez González, Javier, Monreal, Mayte, Ayani Almagia, Ignacio, Llaudó Garín, Jordi, Ochoa Díaz de Monasterioguren, Lourdes, Gutierro Adúriz, Ibón
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5865560/
https://www.ncbi.nlm.nih.gov/pubmed/29593380
http://dx.doi.org/10.2147/DDDT.S162817