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A double-blind, placebo-controlled study of the pharmacokinetics and safety of multiple doses of recombinant human erythropoietin [rHuEPO 150 or 300 U/kg either by intravenous (IV) bolus or subcutaneously (SC)] in normal male subjects demonstrated that rHuEPO had a dose- related effect on the hematocrit independent of the route of administration and that multiple doses of rHuEPO had no direct pressor effects. When rHuEPO was injected IV, a monoexponential decrease in serum EPO level was evident for 18 to 24 hours postdose. Absorption of SC injected rHuEPO occurred more slowly, with relatively low serum EPO levels being maintained for 48 hours. All rHuEPO antibody titer determinations were negative. With the exception of significant increases in hemoglobin and hematocrit, no clinically significant changes occurred. No hypertensive, convulsive, or thrombotic events were observed. Of the adverse experiences observed in 10 subjects, none was considered clinically significant, and none of the subjects dropped out because of adverse experiences.

The effects of various single oral doses of micronized benzbromarone on serum and urinary uric acid and urinary oxypurines were studied in 5 healthy volunteers and in 5 patients with gout. There was an effective, unequivocal, and dose-related reduction in serum uric acid levels in both groups. The simultaneous increased excretion of urinary uric acid but not of oxypurines suggests the mechanism of effect is uricosuria. The prolonged duration of action up to 48 hours after dosing is advantageous as the drug need be taken only once a day. The data presented favor a protracted trial of benrbromarone in patients with gout and hyperuricemia.

l-(2-pyrimidinyl)-4-imino-l, 4-dihydropyridine hydrochloride is a new compound which after oral administration of a single dose of 400 mg. causes significant reductions of hyperglycemia and insulin response in human subjects after an oral glucose load. These results were obtained when compared to a single dose of 200 mg. of phenformin hydrochloride or placebo in a double-blind completely randomized crossover study with placebo and phenformin. Both drugs also produced a significant fall in the fasting serum glucose value before the oral glucose load without any significant effect on serum insulin values. Both drugs produced similar adverse symptoms in the six healthy subjects who participated in the study. DIABETES 20: 734-38, November, 1971.

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