Comparative bioequivalence study of a generic formulation of fingolimod capsule against the innovator fingolimod capsule in fasting healthy subjects

INTERVENTION: Single dose, crossover study design whereby each participant receives the test formulation of fingolimod (3 x 0.5 mg) on one occasion and the innovator formulation of fingolimod (3 x 0.5 mg) on one occasion with each dose seperated by a six week washout period. The intervention for this trial is the test formulation of fingolimod. Each dose will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose). Participants are required not to eat for 10 hours before receiving each dose and to fast for approximately 4 hours after receiving each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored and for 24 hours after dosing. Screening (pre study) and post study laboratory tests will be completed to assess the health of participants. CONDITION: Bioequivalence study conducted in healthy volunteers comparing two formulations of fingolimod with no health condition or problem studied. Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, fingolimod belongs to a class of medicines called asphingosine 1‐phosphate modulators. It it used in the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. PRIMARY OUTCOME: To compare the bioavailability of fingolimod (as summarised by Cmax and AUC) for the two formulations. All plasma samples will be assayed for fingolimod using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines. SECONDARY OUTCOME: Time to maximum peak concentration (Tmax) and the elimination half life (t1/2). Tmax will be the time where the maximum concentration occurred in the sample points. T1/2 = 0.693/Kel where kel is the terminal elimination rate constant. INCLUSION CRITERIA: Healthy males and non‐pregnant females Aged between 18 and 45 Non‐smoker BMI between 18 and 25 inclusive Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Able to provide written informed consent