건강한 한국인 피험자에서 Cefcapene Pivoxil Hydrochloride 75 mg 제제의 생물학적동등성시험
Pharmacokinetic Properties and Bioequivalence of Cefcapene Pivoxil Hydrochloride 75 mg in Korean Healthy Volunteers
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Cefcapene pivoxil hydrochloride, is an ester-type oral cephem antibiotic. This study was performed to compare the pharmacokinetics and evaluate the bioequivalence of two cefcapene pivoxil hydrochloride 75 mg formulations. Method: In a randomized 2×2 crossover study, sixty healthy male volunteers were randomly assigned into two groups. After a single dose of 75 mg cefcapene pivoxil hydrochloride oral administration, blood samples were collected at specific time intervals from 0-12 hours. The plasma concentrations of cefcapene pivoxil hydrochloride were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The pharmacokinetic parameters such as AUClast, AUCinf and Cmax, were calculated and the 90% confidence intervals for test/reference ratio for pharmacokinetic parameters were obtained by analysis of variance on logarithmically transformed data. Results: The mean value for AUClast in test and reference drug was 4053.1±876.5 ng·hr/mL and 3595.7±1029.1 ng·h/mL, respectively. The mean value for Cmax in test and reference drug was 1324.9±321.4 ng/mL and 1159.1±335.9 ng/mL, respectively. The 90% confidence intervals of the AUClast and Cmax ratio for test drug and reference drug were log 1.09-log1.22 and log 1.09-log1.24, respectively. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. Conclusion: This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in these health volunteers. Both formulations were safe and well tolerated in 75 mg of cefcapene pivoxil hydrochloride
Abstract
Cefcapene pivoxil hydrochloride, is an ester-type oral cephem antibiotic. This study was performed to compare the pharmacokinetics and evaluate the bioequivalence of two cefcapene pivoxil hydrochloride 75 mg formulations. Method: In a randomized 2×2 crossover study, sixty healthy male volunteers were randomly assigned into two groups. After a single dose of 75 mg cefcapene pivoxil hydrochloride oral administration, blood samples were collected at specific time intervals from 0-12 hours. The plasma concentrations of cefcapene pivoxil hydrochloride were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The pharmacokinetic parameters such as AUClast, AUCinf and Cmax, were calculated and the 90% confidence intervals for test/reference ratio for pharmacokinetic parameters were obtained by analysis of variance on logarithmically transformed data. Results: The mean value for AUClast in test and reference drug was 4053.1±876.5 ng·hr/mL and 3595.7±1029.1 ng·h/mL, respectively. The mean value for Cmax in test and reference drug was 1324.9±321.4 ng/mL and 1159.1±335.9 ng/mL, respectively. The 90% confidence intervals of the AUClast and Cmax ratio for test drug and reference drug were log 1.09-log1.22 and log 1.09-log1.24, respectively. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. Conclusion: This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in these health volunteers. Both formulations were safe and well tolerated in 75 mg of cefcapene pivoxil hydrochloride
참고문헌 (8)
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