None listed
Conditions
Interventions
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 ?
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: i. Known hypersensitivity or idiosyncratic reaction to mycophenolate mofetil or any related drug. ii. Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. iii. Ingestion of a medicine at any time in 14 days before dosing of period-I. In any such case subject selection will be at the discretion of the Principal Investigator. iv. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria. v. A recent history of alcoholism (2 years) or of moderate (180 mL / day) alcohol use, or consumption of alcohol within 48 hour prior to receiving study medicine. vi. Grapefruit, grapefruit juice and recreational drugs for 48 hours prior to IP administration. vii. Smokers, who smoke 10 or more cigarettes per day and / or unable to abstain from smoking during the study. viii. The presence of clinically significant abnormal laboratory values during screening. ix. Any history of drug addiction or testing positive in pre study drug scan. x. History of psychiatric disorders. xi. A history of difficulty in donating blood. xii. Donation of blood (1 unit or 350 mL) or receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study medicine. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study. Note: In case the blood loss is ¡Ü 200 mL, subject may be enrolled 60 days after blood donation. xiii. A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies. xiv. A positive test result for HIV antibody and / or syphilis. xv. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine and throughout the subjects¡¯ participation in the study. In any such case subject selection will be at the discretion of the Principal Investigator. xvi. Uric acid parameters at the time of screening is not within clinically acceptable range
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 bioequivalenceTimepoint: 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
| Measure | Time frame |
|---|---|
| To monitor the safety of the subjectsTimepoint: 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). | — |
Countries
India
Contacts
Public ContactDr Pankaj Kumar Jha
Outcome results
None listed