Comparative assessment of the absorption of a generic formulation of Dimethyl (2E)-but-2-enedioate capsule against the innovator Dimethyl (2E)-but-2-enedioate capsule conducted under fasting condition in healthy male and female volunteers.

INTERVENTION: Single dose, 3 period, partial replicate, reference scaled, crossover study design whereby each participant receives the test formulation of 240 mg Dimethyl (2E)‐but‐2‐enedioate capsule on one occasion and the innovator formulation of 240 mg Dimethyl (2E)‐but‐2‐enedioate capsule on two occasions with each dose separated by a one week washout period. The intervention for this trial is the test capsule formulation. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for 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. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing. Each dose ( 1 x 240 mg) 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. CONDITION: Dimethyl (2E)‐but‐2‐enedioate is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.; ; Dimethyl (2E)‐but‐2‐enedioate is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability. Neurological ‐ Multiple sclerosis PRIMARY OUTCOME: To compare the bioequivalence of (E)‐4‐methoxy‐4‐oxobut‐2‐enoic‐acid (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for (E)‐4‐methoxy‐4‐oxobut‐2‐enoic‐acid using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.[Prior to dosing and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12 and 14 hours post dosing] SECONDARY OUTCOME: Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.[Prior to dosing and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12 and 14 hours post dosing] INCLUSION CRITERIA: Healthy males and non‐pregnant female volunteers. Aged between 18 and 55 Non‐smoker BMI between 18.5 and 32 Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Able to provide written informed consent