PHASE-1 CLINICAL STUDY OF CEFETAMET PIVOXIL (II)
スポンサーリンク
概要
- 論文の詳細を見る
We performed a phase-1 study on cefetamet pivoxil, a new oral cephalosporin antibiotic, to evaluate its safety and pharmacokinetics in healthy adult male volunteers. A single-dose study of 1, 000mg after meals and a multiple-dose study at a daily dose of 1, 500mg (500mg t. i. d. 19 times over 7 days) were conducted. As to safety, soft stool was transiently observed in two volunteers in the multiple-dose study. No other subjective or objective symptoms, nor abnormalities in physical or laboratory tests attributable to the drug, were observed. In the single-dose study vesults were: T<SUB>max</SUB> 3.58h, C<SUB>max</SUB> 7.40μg/ml AUC 54.6μg·h/ml and T<SUB>1/2</SUB> 2.09h. The urinary recovery amounted to 47.2% in the first 24h. No evidence of accumulation was observed after the multiple-dose study, since the pharmacokinetic parameters after the 19th dose were similar to those for the single-dose study of 500mg after a meal. The effects on intestinal bacterial flora were examined in the volunteers allocated to the multiple-dose study. The total count of anaerobes and some aerobes (for instance, <I>Escherichia coli, Klebsiella</I> sp. and <I>Enterobacter cloacae</I>) decreased, but the intestinal bacterial flora rapidly returned to the baseline after the final administration. From these results, we conclude that cefetamet pivoxil is well tolerated in humans and has a good pharmacokinetic profile suitable for a phase-2 clinical study.
- 公益社団法人 日本化学療法学会の論文
公益社団法人 日本化学療法学会 | 論文
- DISPOSITION OF 7432-8 IN RATS (I)
- CLINICAL STUDIES ON T-1220 IN SURGICAL CASES
- CLINICAL STUDIES OF PIVALOYLOXYMETHYL D-α-AMINOBENZYL-PENICILLINATE HYDROCHLORIDE IN SURGICAL INFECTIONS
- STUDIES ON AC-1370
- Primary treatment with a combination of cyclophosphamide, vincristine, and dacarbazine for recurrent malignant pheochromocytoma: A case report.