Relative bioavailability of 5 ISMN sustained release capsules in normal volunteers

To study the relative bioavailability of 5 ISMN sustained release capsules,18 healthy volunteers were given single or multiple oral dose in a randomized crossover study. The concentration of 5 ISMN in plasma was determined by GC. After a single dose (40 mg), C max of 5 ISMN were (348 3±146 8)ng/mL and(347 9±202 4)ng/mL, T max (4 7±1 8)h and (4 6±1 7)h, AUC (0- n ) (3 933 2±1 425 0)ng·h/mL and (3 693 0±1 239 5)ng·h/mL for test formulation(T) and reference formulation(R), the relative bioavailability was(106 6±16 9)%.Following the multiple dose, C max in the steady state were (230 9±72 4)ng/mL and(190 9±66 9)ng/mL, C min (42 6±23 5)ng/mL and(47 4±22 1)ng/mL,AUC SS ( 2 939 4± 922 1)ng·h/mL and(2 667 4±832 9)ng·h/mL,DF 1 6±0 4 and 1 3±0 3 for T and R, the relative bioavailability was(111 02±21 05)%. The result of the statistic analysis showed that the two preparations were bioequivalent.