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KMID : 0391020130210020104
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2013 Volume.21 No. 2 p.104 ~ p.112
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Pharmacokinetic Characteristics of Cefcapene Pivoxil Hydrochloride after Single Oral Administration in Healthy Korean Subjects
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Lee Su-Jin
Shin Kwang-Hee
Cha Yu-Jung
Kim Jung-Ryul
Oh Dal-Seok
Cho Joo-Youn
Yu Kyung-Sang
Jang In-Jin
Chung Jae-Yong
Lim Kyoung-Soo
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Abstract
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Background: Cefcapene pivoxil hydrochloride (CFPN-PI) is an oral ester cephalosporin antibiotic with a broad spectrum. In this study, we investigated the pharmacokinetics (PK) and tolerability of CFPN-PI following single oral administration in healthy Korean subjects.
Methods: An open?label, dose?escalation, parallel group study was conducted in 18 healthy male volunteers. A single dose of CFPN-PI was administered to 6 subjects in each treatment group of 100, 150 and 200 mg. Serial blood and urine samples were collected up to 12 h and 24 h after dosing, respectively. Plasma and urine concentrations of cefcapene were measured by HPLC-UV. PK parameters were estimated using non-compartmental analysis. For the safety evaluation, adverse event monitoring, clinical laboratory tests and physical examination were performed throughout the study.
Results: Median values of time to peak plasma concentration were observed around 1.5 to 2.0 h. Maximum plasma concentrations (Cmax) were 1.04 ± 0.22, 1.24 ± 0.46 and 1.56 ± 0.43 mg/L (mean ± SD), and area under the plasma concentration?time curve (AUCinf) were 2.94 ± 0.46, 3.97 ± 1.28 and 4.70 ± 1.19 h*mg/L in 100, 150 and 200 mg dose groups, respectively. The differences of dose?normalized Cmax and AUCinf among three groups were not statistically significant. The fractions of drug excreted in urine unchanged were 31.5 % - 42.9 %. There were no serious adverse events or clinically significant abnormalities related to CFPN-PI.
Conclusion: CFPN-PI was well tolerated with single oral administration and showed a linear PK property within 100 - 200 mg in healthy Korean male subjects.
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KEYWORD
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Cefcapene pivoxil hydrochloride, Pharmacokinetics, Tolerability, Korean, Healthy subjects
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