RELATIVE BIOAVAILABILITY OF A SLOW-RELEASED FORMULATION OF TRANILAST IN NORMAL VOLUNTEERS
Fei Zhao · The Chinese Journal of Clinical Pharmacology · 1996
The relative biavailability of a slow released and conventional formulations of tranilast were determined after a single and multiple oral dose of tranilast given to volunteers in an open randomized crossover study. After a single oral dose (200 mg)the peak levels in plasma averaged 29.8±3.8 and 36.5±6.3 mg/ L at 4.5±0.8 and 3.2±1.3 h and t he AUC were 461.6±77.5 and 45 1.3±89.1 mg. h-1. L-1 for slow-released and conventional formulations respectively.The relative bioavailavility of slow - released formulation was 103.3±10.3%.Following multiple dosing mean steady state Cmax values were 43.1±7.6 and 42.7±11.5 mg/L and mean Cmin values were 24.5±5.8 and 21.2±7.6 mg/L for slow released and conventional formulation respectively. The peak-to-through fluctuation index(FI)for the two formulations were 56.2±10.0 and 68.3±30.2,respectively.The result of two one sided tests showed that the two formulations were bioequivalent.