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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...
Autores principales: | Martínez González, Javier, Monreal, Mayte, Ayani Almagia, Ignacio, Llaudó Garín, Jordi, Ochoa Díaz de Monasterioguren, Lourdes, Gutierro Adúriz, Ibón |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2018
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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 |
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