Details

Autor(en) / Beteiligte

• 조혜영
• Hea Young Cho
• 강현아
• Hyun Ah Kang
• 김세미
• Se Mi Kim
• 박찬호
• Chan Ho Park
• 오인준
• In Joon Oh
• 임동구
• Dong Koo Lim
• 문재동
• Jai Dong Moon
• 이용복
• Yong Bok Lee

Titel

단보 : 시클러 캡슐(세파클러 250㎎)에 대한 경보세파클러 캡슐의 생물학적동등성

Ist Teil von

• Journal of pharmaceutical investigation, 2005-02, Vol.35 (1), p.39

Ort / Verlag

한국약제학회

Erscheinungsjahr

2005

Link zum Volltext

Beschreibungen/Notizen

• The purpose of the present study was to evaluate the bioequivalence of two cefaclor capsules, Ceclor (Lilly Korea Co., Ltd.) and Kyongbocefaclor (Kyongbo Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of cefaclor from the two cefaclor formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2. 4.0. 6.8 buffer solution and water). Twenty four healthy male subjects. 22.96±1.52 years in age and 67.03±7.90 kg in body weight, were divided into two groups and a randomized 2x2 cross-over study was employed. After one capsule containing 250 mg of cefaclor was orally administered, blood was taken at pre-determined time intervals and the concentrations of cefaclor in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition. the pharmacokinetic parameters such as AUC_(t), C_(max) and T _(max) were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUC_(t). C_(max) and untransformed Tmaa. The results showed that the differences between two formulations based on the reference drug, Ceclor. were -1.90%, 2.68% and -7.60% for AUCt, C_(max) and T_(max), respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.91-log 1.06 and log 0.92-log 1.18 for AU`, and C_(max), respectively). Thus. the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kyongbocefaclor capsule was bioequivalent to Ceclor capsule.