Bioequivalence Study of a Test Capsule Formulation of Fingolimod With the Reference Capsule Formulation of Fingolimod
Status:
Completed
Trial end date:
2016-01-26
Target enrollment:
Participant gender:
Summary
The study evaluates the bioequivalence of the Test formulation, 0.5 mg Fingolimod HCl capsule
(Asofarma S.A.I. y C. on behalf of Tolmar, Batch No. 22264), relative to that of the
Reference formulation, 0.5 mg Gilenya® (fingolimod) capsule (Novartis Pharmaceuticals, Batch
No. S0099), following oral administration of a single oral dose of 3 x 0.5 mg in healthy,
adult, male and female subjects under fasting conditions.