Pharmacokinetics and tolerance of a new penem antibiotic,FCE 22101, in healthy volunteers after a single intravenous dose |
| |
Authors: | M. G. Jannuzzo M. Mandelli M. Strolin Benedetti E. Moro M. Carnovali R. Vaiani D. Sassella |
| |
Affiliation: | (1) Research and Development, — Erbamont Group, Farmitalia Carlo Erba, Milan, Italy;(2) Ospedale di Circolo di Rho, Milan, Italy |
| |
Abstract: | Summary The clinical tolerance and pharmacokinetics of FCE 22101 (sodium (5R, 6S)-6-[(1R)-hydroxyethyl]-2-carbamoyloxymethyl-2-penem-3-carboxylate), a new penem antibiotic, have been studied after giving a single i.v. dose of 4 mg·kg–1 to ten healthy male volunteers. The pharmacokinetics was estimated according to a two-compartment open model. The peak plasma concentration (Cmax) was 15.5 (1.08) µg·ml–1, mean (SEM). FCE 22101 was rapidly cleared from the systemic circulation [=44.2 (4.2) min; CL=7.21 (0.47) ml·kg–1·min–1]. The mean apparent volume of distribution at steady-state was 246 (16.9) ml·kg–1. The mean residence time relative to the 10 min infusion was 39.4 (1.5)min. Urinary recovery of FCE 22101 showed wide inter-subject variation, ranging from 10.2 to 53.6% of the dose. No subject complained of adverse effects. |
| |
Keywords: | FCE 22101 penem antibiotic pharmacokinetics single dose healthy volunteers adverse effects |
本文献已被 SpringerLink 等数据库收录! |
|