PHASE I STUDIES ON CEFOTIAM (SCE-963) ADMINISTERED INTRAVENOUSLY
1979 Volume 27 Issue Supplement3 Pages 181-191
Details
1979 Volume 27 Issue Supplement3 Pages 181-191
A phase I study on cefotiam (SCE-963), a new injectable cephalosporin, was carried out on total 15 healthy adult volunteers. Cefotiam was administered in a single shot at doses of 125, 250 and 500 mg intravenously (i. v.), 1000mg/2 hr. by intravenous drip infusion (i. v. d.), twice 1000 mg/30min. i. v. d. at a 6-hour interval and 2000 mg/lhr. i. v. d. 1000 mg cefotiam/2hr. i.v.d. study was performed following double blind crossover design against physiological saline solution for comparison.
Subjective and objective symptoms, blood pressure, heart rate, ECG, respiratory rate, hematological examination, blood chemistry tests, urinalysis were examined before and after administration at regular time intervals for attesting the safety of the drug. Serum concentrations and urinary excretion of cefotiam were also examined.
1. As to subjective and objective symptoms as well as other test results including liver and renal function tests, no significant change attributable to the drug were noted.
2. High serum concentration of cefotiam in proportion to the administered doses was obserevd. Elimination of the drug was rapid and its biological half-life was about 40 minutes in i.v. administration. 65-70 % of the administered doses was excreted into the urine by 6 hours after the administration, giving urinary high concentration. Following excretion, however, was scanty. Two repeated doses of 1000 mg/30min. i.v.d. at a 6-hour interval did not show any tendency of the drug accumulation in the body.
