Absorption of aluminum from aceglutamide aluminum in healthy adult males.

The absorption of aluminum was studied in twelve healthy male volunteers over a period of fourteen days in a placebo-controlled, double blind study. All subjects were institutionalized during the study. Eight subjects (treated group) received ascending doses of aceglutamide aluminum (N-acetyl-L-glutamine aluminum complex) administered in multiple daily doses. The remaining four subjects (untreated group) received placebo. Systemic absorption and excretion of aluminum were evaluated by measuring aluminum concentrations in serum, urine and fecal samples. Aluminum concentrations were determined by electrothermal atomic absorption spectrometry. All serum aluminum concentrations were less than 16 micrograms/L for both groups. The mean urinary and fecal aluminum concentrations in the aluminum-treated group were significantly higher than in the untreated group during the study days the drug was administered. The total amount of aluminum (as aceglutamide aluminum) given to each treated subject during the 14 day study period as 3290 mg. The mean total fecal aluminum concentration was 3318 mg for the treated group and 269 mg for the untreated group during the study period. These findings are consistent with the view that some aluminum absorption from the gastrointestinal tract occurred following the administration of the drug. The absorbed aluminum appears to have been rapidly excreted in the urine and the feces.