Bioequivalence Study Of MYCOCEPT 500mg

To assess the bioequivalence by comparing the single oral dose bioavailability of test product MYCOCEPT 500mg (containing Mycophenolate mofetil 500 mg) film coated tablets manufactured by (confidential) with that of reference product CELLCEPT 500mg (containining Mycophenolate mofetil 500 mg) film coated tablets distributed by Roche Registration Limited, shire park, welwyn Garden City, AL7 1TW, UK in healthy, adult, human subjects under fasting conditions.
4.2. STUDY DESIGN A randomized, open label, balanced, two treatments, two periods, two sequence, cross over, single oral dose bioequivalence study of Mycophenolate mofetil 500 mg tablets in 24 Normal , Healthy , Adult ,Male human Subjects under fasting condition.
1. Flexibility …show more content…
4.2.11. Pharmacokinetic parameters: Pharmacokinetic parameters Cmax , AUC0-t , AUC0- α , Tmax , t1/2 , Kel and AUC_% Extrapolation Observations will be estimated for Mycophenolate mofetil and its active metabolite Mycophenolic acid (MPA) by using Phoenix WinNonlin 6.3.
4.2.12. Statistical Analysis:
Summary statistics, ANOVA, intra subject variability, 90% confidence intervals and power will be calculated using SAS version 9.2.
4.2.13. Safety Assessments:
 In each period, vital signs monitoring will be carried out at the time of each period check-in, pre-dose and at 1.00, 3.00, 6.00, 10.00, 24.00 (with a window period of ± 0.75 hrs), and 26.00, 35.00, 50.00, 59.00 (with a window period of ± 1.00 hr) and 72.00 (with a window period of ± 4.00 hrs) hours post-dose, respectively.
 The breath of the subjects will be checked for alcohol consumption at the time of each period check-in by using a breath alcohol analyzer.
 Medical examination will be done at the time of each period check-in, at the time of Period-II check-out (72.00 ± 4.00 hrs post-dose) and whenever the attending Medical Officer thinks it