Bioequivalence Study of a Test Capsule Formulation of Fingolimod With the Reference Capsule Formulation of Fingolimod

This was a single centre, single dose, blinded, two treatment, two period, two sequence, two-way crossover, randomized study conducted under medical supervision at Zenith Technology Corporation Limited's Clinical Site and involving 32 healthy adult subjects.

All subjects received either the Test or the Reference product under fasting conditions in each of the two treatment periods. In Period 1, one half of the subjects (16) were scheduled to receive 3 x 0.5 mg Fingolimod HCl capsules (Test); and one half of the subjects (16) were scheduled to receive 3 x 0.5 mg Gilenya® capsules (Reference). Each subject was scheduled to receive the alternate treatment in Period 2.

The two treatments were administered with 240 ml of ambient-temperature water after an overnight fast of at least 10 hours. Subjects did not receive any food until at least 4 hours post-dose. The capsules were swallowed whole.

During each study period, subjects were confined to the Zenith Clinical Site from at least 12 hours prior to drug administration, until after the 24-hour post-dose blood draw. Blood samples (18 x 10 ml) were collected at specified intervals during the in-house period from pre-dose (0 hours) out to 24 hours post-dose. Subjects returned to Zenith premises for the collection of additional blood samples (4 x 10 ml) at 32, 48, 56 and 72 hours post-dose. A total of 22 x 10 ml blood samples were collected in each study period.

The doses in the two treatment periods were separated by a washout period of at least 42 days and the project duration was 46 days for subject dosing and blood sampling over two periods.