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