Clinico-pharmacological Study of a New Diuretic Agent, FR 3068

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A new diuretic agent, FR 3068 (tienilic acid) was studied for effects on urinevolume, urinary and serum electrolytes and uric acid, for serum and urinary con-centration of unchanged FR 3068 and for tolerability in 33 healthy male volunteers. A single oral dose of 250mg of FR 3068 increased significantly urine volume for 4 hours and urinary excretion of Na and Cl for 6 hours, but didn't cause significant changes in urinary K excretion and serum electrolytes.<BR>Urinary excretion of uric acid increased for 4 hours after administration of 125 mg and for 6 hours after 250mg, and serum uric acid at 8 hours after administration decreased significantlyin correlation with dosages of 62.5, 125 and 250mg.<BR>Peak serum concentration of unchanged FR 3068 was obtained 1 to 2 hours after a single oral administration and urinary recovery of unchanged FR 3068 in 24 hours was 17.3% after 62.5 mg, 22.3% after 125 mg and 37.9% after 250 mg. Any side effects and abnormalities in laboratory tests, ECG and audiogram were not observed during the study.<BR>It is considered that FR 3068 is an unique diuretic agent with a marked urico-suric effect.
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