IRCT20200623047902N34 IRCT 2023-04-17 Alborz Zagros company Bioequivalence study of Fingolimod capsule 0.5 mg Bioequivalence study of Fingolimod capsule 0.5 mg manufactured by Alborzzagros versus originator brand in healthy volunteers in the fasted condition 2023-04-21 anticipated 24 Complete https://irct.ir/trial/69027 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball, poured into a container, and mixed. The balls are then removed randomly from the container and divided in 2 groups of 12 test (A) and reference (B) drug recipients, then in the second phase, groups A and B will be cross-referenced to the test and drug recipients, Blinding description: This study is a single-blinded clinical trial (volunteers). Alborzzagros's fingolimod and Originator brand capsules are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form. Bioequivalence This study is performed on healthy volunteers.. Intervention 1: This study examines the bioequivalence of fingolimod capsules produced by Alborzagros company versus foreign brand samples. There is only one intervention group and no control group. The intervention group, which includes healthy and fasting volunteers, who will receive a single dose, 2 half-mg capsules made by Alborzagros or Novartis pharmaceutical company, in two 72-hour periods with an interval of 8 weeks. After 8 weeks, the study will continue with another drug. Intervention 2: Control group: single dose, two oral capsules of Geliniya 0.5 mg manufactured by Novartis, as a reference product. No - There is not a plan to make this available Justification or reason for not sharing IPD is These data are as secure between researchers and related industries.