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
Article
in English
| 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
Full text:
Available
Index:
LILACS (Americas)
Main subject:
Capsules
/
Therapeutic Equivalency
/
Randomized Controlled Trials as Topic
/
Follow-Up Studies
/
Dimethyl Fumarate
Type of study:
Controlled clinical trial
/
Observational study
/
Prognostic study
Limits:
Adult
/
Humans
Language:
English
Journal:
Prensa méd. argent
Journal subject:
Medicine
Year:
2017
Type:
Article
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