Abstract
Serum concentrations, relative bioavailability, and urinary excretion of pinacidil [(±)-2-cyano-1-(4-pyridyl)-3-(1,2,2-trimethylpropyl)guanidine monohydrate] from two sustained-release oral formulations (tablet and capsule) were compared in 12 healthy volunteers. Maximum measured serum concentrations (Cmax) from the sustained-release tablet and capsule did not differ significantly (75 ± 17 versus 70 ± 14 ng/mL, p > 0.05), but the time to achieve maximum concentration (tmax), was longer for the capsule (2.4 ± 1.8 versus 0.98 ± 0.5 h, p < 0.05), There was no significant difference in bioavailability between the formulations, as measured by the area under the concentration—time curve (AUCo—8 h; 279 ± 99 versus 311 ± 85 ng·h/mL, p > 0.05). Twenty-four hour urinary excretion of both pinacidil and its major metabolite, pinacidil pyridine-N-oxide, was similar for both tablet and capsule preparations (3.9 ± 1.2 and 55 ± 19% versus 4.4 ± 1.0 and 55 ± 14%, respectively, of the administered dose, p > 0.05).
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