Healthy Volunteers Clinical Trial
Official title:
A Randomized, Single Dose, Crossover, Bioequivalence Study of Fingolimod 0.5 mg Capsule (Asofarma S.A.I. y C., Argentina) Compared With Gilenya 0.5 mg Capsule (Novartis Pharmaceuticals, Australia Pty Ltd) in Fasting Healthy Subjects
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.
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.
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