Relative bioavailability of fingolimod (2Ã?0.25 mg) vs. FMI, 0.5 mg capsule in healthy volunteers

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2012
INTERVENTION: Intervention1: Fingolimod (FTY720) new capsule formulation 0.25 mg (Test): Single dose as 2x0.25 mg Control Intervention1: (1Ã?0.5 mg) Fingolimod (FTY720) FMI capsule (Reference): Single Dose CONDITION: Adults, Healthy Volunteers PRIMARY OUTCOME: To determine the relative bioavailability of new fingolimod formulation (2 Ã? 0.25 mg) against the Final Market Image (FMI, 0.5 mg)‐‐‐‐‐‐Timepoint: Two single dose treatment periods, seperated by a washout of 36 days between dosing and end‐of study evaluation at the last PK sample time point SECONDARY OUTCOME: To assess safety and tolerability of a single fingolimod dose in healthy volunteers.‐‐‐‐‐‐Timepoint: Monitoring of AE throughout the study INCLUSION CRITERIA: 1. Healthy subjects 2. Female subjects must be of non‐child bearing potential 3. Subjects must weigh at least 50 kg and their BMI should be within range of 18‐30 kg/m2
Epistemonikos ID: 0c3dc03d14bf2d265cf226c04e9f7ac1b65e4645
First added on: Aug 22, 2024