Phase 1 study of azosemide (SK-110): single- and multiple-dose study.

Single and multiple doses of SK-110 were administered orally to healthy volunteers. No subjective or objective symptoms were observed in tests I-I, I-II, I-III, and II, with the exception of dehydration, considered to be a direct effect of the diuretic, which was observed in test I-III. No noteworthy abnormalities were observed in laboratory examinations. One hour after administration of SK-110, urinary output and excretion of urinary electrolytes increased. In test II the diuretic effect of SK-110 continued for about 9 h after administration. Plasma concentration of SK-110 increased in proportion to the doses, and peak concentration was observed 3-4 h after administration. Plasma concentration of SK-110 on the 1st and 5th day of administration showed the same patterns. Drug excretion in the urine was less than 10%.