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The effect on haemodynamics, pharmacokinetics, and safety of BTS 49 465 (flosequinan; 7-fluoro-1-methyl-3-methylsulphinyl-4-quinolone) were investigated in six healthy volunteers after single oral administration and in six other healthy volunteers after repeated oral administration. The antihypertensive action of BTS 49465 was observed beginning from 30min after single oral administration and continuing for 6hr. Pulse rate increased in accordance with the decrease in blood pressure. A steady state of plasma BTS 53554, a major metabolite of flosequinan, was achieved on day 6 of multiple oral administration. The t1, 2 (biological half life) after the final dose of the repeated administration was the same as that after single administration. This study demonstrated that BTS 49465 is rapidly absorbed by the gastrointestinal tract given that the tmax (peak time) of BTS 49465 is 30min. The t112 of BTS 49465 is 2.1hr, while the t1, 2 of BTS 53554 is 29hr, which supports a once-daily regimen. Two percent of BTS 49465 and 51% of BTS 53554 were excreted in the urine within 96hr after flosequinan administration. After multiple oral administration BTS 53554 plasma concentration reached a steady state on day 6 and on day 10. After final dosing, the t1, 2 was comparable to that after single oral administration. BTS 49465 and BTS 53554 did not accumulate in the body after multiple oral

Haemodynamics and Pharmacokineticsof Flosequinan (BTS 49 465) after Single and Multiple Oral Administration in Healthy Volunteers.