Bioequivalence study of Cladribine 10 mg tablet in highly active relapsing multiple sclerosis patients

INTERVENTION: Intervention1: Test products (T): Cladribine Tablets 10 mg manufactured by Arab Pharmaceutical Manufacturing Company, Jordan for Hikma Pharmaceuticals, Jordan (MAH): In each period, after overnight fasting of at least 8 hours, a single dose of either Test product (T) or Reference product (R) will be administered orally to the subjects as per the randomization schedule in sitting posture with about 240 mL of water at ambient temperature in the morning Control Intervention1: Reference products (R): MAVENCLAD® (Cladribine) Tablets 10 mg manufactured by NerPharMa S.R.L., Italy for Merck Europe B.V., Netherlands (MAH).: In each period, after overnight fasting of at least 8 hours, a single dose of either Test product (T) or Reference product (R) will be administered orally to the subjects as per the randomization schedule in sitting posture with about 240 mL of water at ambient temperature in the morning CONDITION: Health Condition 1: G35‐ Multiple sclerosis PRIMARY OUTCOME: To assess the bioequivalence of Cladribine Tablets 10 mg manufactured by Arab Pharmaceutical Manufacturing Company, Jordan for Hikma Pharmaceuticals, Jordan (MAH) and MAVENCLAD® (Cladribine) Tablets 10 mg manufactured by NerPharMa S.R.L., Italy for Merck Europe B.V., Netherlands (MAH), in 40 adult patients with highly active relapsing multiple sclerosis (MS) under fasting conditionsTimepoint: In each period, total of 19 (04 mL each) blood samples will be collected at 0.00 (pre‐dose) and at 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post‐dosing SECONDARY OUTCOME: To monitor the safety of patients.Timepoint: Safety parameters like Physical examination, safety laboratory parameters assessment (screening, mid study safety and post study), adverse events, vital signs will be recorded in the study to monitor the safety throughout the study period ; INCLUSION CRITERIA: 1. Adult patients who are diagnosed with highly active relapsing multiple sclerosis (MS) according to the McDonald criteria at the time of screening as per the principal investigator. 2. Male or female, between 18 and 65 years of age. 3. Weighed between 40‐99 kilogram (kg). 4. Subject with Lymphocyte count normal as per lower limit of normal range (of the central laboratory) for Year 01 treatment and greater than 800 cells/mm³ for Year 02 treatment. 5. Has a physical condition which enable patients to be fit for a Pharmacokinetic sampling according to principal investigator evaluation. 6. If female, she must: â?¢ be post‐menopausal or surgically sterilized; or â?¢ uses a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study and willing to continue the same for 6 months from the last dose. â?¢ And be neither pr