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
; Prensa méd. argent;103(10): 553-555, 20170000. tab
Article
de En
| LILACS, BINACIS
| ID: biblio-1371607
Bibliothèque responsable:
AR392.1
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
Texte intégral:
1
Indice:
LILACS
Sujet Principal:
Capsules
/
Équivalence thérapeutique
/
Essais contrôlés randomisés comme sujet
/
Études de suivi
/
Fumarate de diméthyle
Type d'étude:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Limites du sujet:
Adult
/
Humans
langue:
En
Texte intégral:
La Prensa médica argentina
/
Prensa Med Argent
/
Prensa méd. argent
Thème du journal:
MEDICINA
Année:
2017
Type:
Article