Conclusion Bioequivalence Results:

A total of 40 subjects were planned and enrolled in the study. Thirty-nine (39) subjects completed the clinical phase of the study and data of thirty-nine (39) subjects were considered for pharmacokinetic and statistical analysis. The 90 % CI’s of Ln-transformed parameters for Fingolimod are summarized below: Safety results: Two (02) AEs were reported during the clinical phase of the study which were unexpected and not related to study drug, mild in severity and were considered for lost to follow up. No serious AEs (SAEs) were observed during the clinical phase.

Conclusion:

Based on the statistical analysis of Fingolimod on 39 subjects, it is concluded that the Test Product (T): Fibroneurina manufactured by Laboratorios Bagó, Argentina shows bioequivalence with the Reference Product Fingolimod 0.5 mg hard capsules Manufactured by Novartis Pharma GmbH, Germany.

Date of the report:

04 February 2017