Vol.53 No.S-1 July 2005
Phase I study of doripenem, a new carbapenem antibiotic for injection, in elderly volunteers
1)Hamamatsu Institute of Clinical Pharmacology & Therapeutics,
40-3 Sukenobu-cho, Hamamatsu, Shizuoka, Japan
2)Medical Corporation Aggregate Shinpukai Maruyama Hospital
3)Developmental Research Laboratories, Shionogi & Co., Ltd.
Abstract
We conducted a Phase I pharmacokinetic study of doripenem (DRPM), a new carbapenem antibiotic for injection, in 6 elderly male volunteers. DRPM was administered intravenously at a dose of 250 mg (0.5-hour single infusion). We studied the effects of aging on pharmacokinetic profiles of DRPM by comparison with data in another study in healthy nonelderly male volunteers. We also assessed the safety of DRPM in the elderly.
Significant differences observed in plasma half-life, AUC, and systemic clearance between the elderly and nonelderly were not great. The change in mean plasma DRPM concentration showed no great differences between groups.
No adverse drug reactions were observed.
We concluded that aging has little effect on pharmacokinetic profiles of DRPM after a single dose at 250 mg and thus the dosage and administration intended for the nonelderly also applies to the elderly people with no concern about DRPM safety.
Key word
carbapenem, doripenem, phase I clinical study, elderly, healthy volunteer, pharmacokinetic
Received
January 11, 2005
Accepted
March 28, 2005
Jpn. J. Chemother. 53 (S-1): 124-129, 2005
