Demonstration of bioequivalence between ventasol syrup and ventolin syrup in humans and in dogs
Simon, O.R.; Chang, C.
West Indian Medical Journal 43(2): 39-42
1994
ISSN/ISBN: 0043-3144 PMID: 7941494 Document Number: 428638
Ventasol syrup, a new locally produced salbutamol formulation, was compared with the standard salbutamol formulation, ventolin syrup, for determination of oral bioequivalence in stable asthmatic human subjects and in dogs. On separate occasions, each subject received a single 10 ml oral dose of each formulation containing 4 mg salbutamol. In the human subjects, statistically similar peak plasma concentrations of salbutamol were obtained (196 +/- 7 ng/ml for ventasol syrup and 185 +/- 6 ng/ml for ventolin syrup) 3 hours after oral administration of the formulations. From the ratio of the AUCo-infinity for the formulations (1.04), a relative oral bioavailability of 104%, indicating equivalent total salbutamol output, was also obtained in the human subjects. Similarly, in the dogs, the formulations produced statistically equivalent peak plasma concentrations of salbutamol (259 +/- 24ng/ml for ventasol syrup and 285 +/- 29ng/ml for ventolin syrup) 3 hours after oral administration. Also, from the ratio of the AUCo-infinity for the formulations (1.02), a relative oral bioavailability of 102%, indicating similar total salbutamol output, was obtained in the dogs. From these results, it is concluded that oral bioequivalence between ventasol syrup and ventolin syrup was demonstrated in human subjects and in dogs.