Bioequivalence Study of a Test Capsule Formulation of Fingolimod With the Reference Capsule Formulation of Fingolimod
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): Fingolimod Reference Formulation; Fingolimod Test Formulation
Intervention type(s): Drug; Drug
Intervention description(s): To compare the rate and extent of absorption for Fingolimod when administered as a single oral dose of 3 x 0.5 mg capsules of the reference product produced by Novartis Pharmaceutical with the proposed test product manufactured by Asofarma S.A.I. y C. in healthy volunteers, under fasted conditions.; To compare the rate and extent of absorption for Fingolimod when administered as a single oral dose of 3 x 0.5 mg capsules of the proposed test product manufactured by Asofarma S.A.I. y C. with the reference product produced by Novartis Pharmaceutical in healthy volunteers, under fasted conditions.
Other intervention name(s): Gylenia®; Lebrina®
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single centre, single dose, blinded, two treatment, two period, two sequence, two-way crossover, randomized study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment