The present study was undertaken to investigate the influence of food and gastric acidity on the pharmacokinetics of MPC-1304, a new calcium channel blocker, in two comparison studies.
Study I: A single oral dose of MPC-1304 (5mg) was given to six healthy male subjects with a crossover design during fasting and 30 minutes after meals. Study II: A single oral dose of MPC-1304 (5mg) was given to five subjects with normal gastric acidity and five subjects with low gastric acidity.
The area under plasma concentration curve (AUC0-24hr), the maximum plasma concentration (Cmax), the time to reach the maximum plasma concentration (tmax), the half-life (t1/2) and the cumulative urinary excretion amount were compared by the analysis of variance. In addition, parameters by the moment analysis were calculated.
In study I, there were no significant differences between the values during fasting and those after meals. In study II, there were also no significant differences between the two groups though the interindividual variations were larger in the subjects with low gastric acidity than in the subjects with normal gastric acidity.
We conclude that the influence of food and gastric acidity on the pharmacokinetics of MPC-1304 was considered to be little.
