Pharmacodynamics and tolerability of low doses of tendamistate given with starch

Six healthy male volunteers participated in a double-blind cross-over study in which 12,5 mg, 25 mg, or 50 mg tendamistate (HOE 467), an alpha-amylase inactivator, or placebo were administered with 100 g maize meal, which contains 85,5 g pure starch. Serial blood specimens for measurement of plasma glucose concentrations, which served as a criterion of starch absorption, were taken up to 3 hours after each starch meal, and side-effects were recorded. The administration of HOE 467 with a starch meal resulted in a significant inhibition of starch absorption. Side-effects were not severe. Flatulence occurred in the placebo phase as well as after administration of the active drug. Loose stools were reported by 1 subject after 25 mg tendamistate.