This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q
8-hour schedule) alone and also co administered with a single 1000 mg oral dose of
azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels
of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and
whether there are significant changes in cefixime PK after co-administration. The primary
pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg
doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds
2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg
doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin,
achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to
evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen
of 800
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)