To test the similarity of the same drug ( MYCOPHENOLATE MOFETIL) manufactured by two different companies, Roche and Intas

INTERVENTION: Intervention1: Mycophenolate mofetil 500 mg tablets: The investigational product will be administered to the subjects while in a sitting position after an overnight fast of at least 10 hrs, with 240 ?b 02 mL of water at ambient temperature. This activity will be followed by a mouth check to assess compliance to dosing. Subject will remain in sitting or ambulatory posture for the first 3 hours after administration of IP in each period. Thereafter, the subjects will be allowed to engage only in normal activities while avoiding severe physical exertion. Duration:1 day Control Intervention1: Cellcept® 500 mg tablets: Each tablet containing Mycophenolate mofetil 500 mg ‐ Roche Registration Ltd., UK. Duration:1 day CONDITION: BIOEQUIVALENCE STUDY IN HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FASTING CONDITIONS PRIMARY OUTCOME: To compare the bioavailability and characterise the pharmacokinetic profile of the sponsorâ??s test formulation (Mycophenolate mofetil 500 mg tablets) relative to that of reference formulation (Cellcept® 500 mg tablets) in healthy, adult, human, male subjects under fasting conditions, and to assess the bioequivalence‐‐‐‐‐‐Timepoint: Same day i.e.A total of twenty‐nine (3 mL in case of post dose samples and 5 mL in case of pre dose sample) samples will be collected in each period. The venous blood samples will be withdrawn pre‐dose and at 0.083, 0.167, 0.25, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00, 18.00, 24.00, 30.00, 36.00, 42.00, 48.00 and 60.00 hours post dose administration. SECONDARY OUTCOME: To monitor the safety of the subjects‐‐‐‐‐‐Timepoint: Estimation of haematology parameters will be done within three working days prior to dosing in Period‐II ; Clinical examination of the subjects including vital signs and recording of oral body temperature will be done after check‐in, before checkout in each period and at the time of end study safety assessments (8 ± 1 day after dose administration in Period ?II). ; INCLUSION CRITERIA: i. Healthy adult human male volunteers between 18 to 55 years of age (both inclusive) living in and around Ahmedabad city or western part of India. ii. Having a Body Mass Index (BMI) between 18.5 to 24.9 (both inclusive), calculated as weight in kg / height in m2. iii. Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12 lead ECG and X‐ray chest (postero‐anterior view) recordings. iv. Able to comply with study procedures, in the opinion of the investigator. v. Able to give written consent for participation in the trial.