NFORME DE ESTUDIO DE BIOEQUIVALENCIA FUMARATO DE DIMETILO 240 MG MODIFICADO. Cápsulas de liberación en condiciones alimentadas / BIOEQUIVALENCE STUDY REPORT DIMETHYL FUMARATE 240 MG MODIFIED RELEASE CAPSULES UNDER FED CONDITIONS
Prensa méd. argent
;
103(10): 553-555, 20170000. tab
Artigo
em Inglês
| LILACS, BINACIS
| ID: biblio-1371607
ABSTRACT
All plasma concentrations of subject no. 35 in period II were below the quantification (BLQ ). As there were no significant clinical observations, data 35 were considered for pharmacokinetic and statistical analysis. Hence, data were considered for pharmacokinetic and statistical analysis. However, analysis was also performed excluding subject no. 35 for information purpose. The 90 % confidence intervals of Lntransformed parameters for Monomethyl fumarate are summarized below ; Safety results A total of eight (08) adverse events were reported during the clinical phase of the study, of which four (04) adverse event were probably related to the study drug, three (03) adverse events were unrelated and one (01) adverse event was possibly related to the drug. All the adverse events were mild to moderate in severity and were resolved. No serious adverse events were observed during the study periods. Conclusion Bioequivalence between Test Product Dimethyl fumarate 240 mg modified release capsules (manufacturer Rider Synthon Ltda, Chile) and reference Product Tecfidera® 240 mg gastroresistant hard capsules (MAH Biogen Idec. Ltd., United Kingdom) was demonstrated in this study
Texto completo:
DisponíveL
Índice:
LILACS (Américas)
Assunto principal:
Cápsulas
/
Equivalência Terapêutica
/
Ensaios Clínicos Controlados Aleatórios como Assunto
/
Seguimentos
/
Fumarato de Dimetilo
Tipo de estudo:
Ensaio Clínico Controlado
/
Estudo observacional
/
Estudo prognóstico
Limite:
Adulto
/
Humanos
Idioma:
Inglês
Revista:
Prensa méd. argent
Assunto da revista:
Medicina
Ano de publicação:
2017
Tipo de documento:
Artigo
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