Bioequivalence Studies of 2 Oral Cefaclor Capsule Formulations in Chinese Healthy Subjects
| Autor: | Bo Jiang, Huifang Lou, Zourong Ruan, Ling-yan Yu, Jinliang Chen |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Chemistry
Pharmaceutical Liquid-Liquid Extraction Cmax Capsules Pharmacology Bioequivalence High-performance liquid chromatography Asian People Pharmacokinetics Drug Discovery polycyclic compounds Humans Medicine Cefaclor Chromatography High Pressure Liquid Cross-Over Studies business.industry Crossover study Confidence interval Anti-Bacterial Agents Therapeutic Equivalency Tolerability Area Under Curve business Half-Life medicine.drug |
| Zdroj: | Arzneimittelforschung. 62:134-137 |
| ISSN: | 1616-7066 0004-4172 |
| DOI: | 10.1055/s-0031-1298012 |
| Popis: | An open-label, single-dose, randomized, crossover study was carried out in 20 Chinese healthy male subjects to compare the pharmacokinetics of 2 cefaclor (CAS 53994-73-3) formulations after administration of a single 250 mg dose of each drug with a 1-week wash-out period. Blood samples were collected before and with 6 h after drug administration. Plasma concentrations were determined by high-performance liquid chromatography (HPLC) with UV detector. 2 formulations were evaluated using the following pharmacokinetic parameters: AUC0-t, Cmax and tmax was analyzed nonparametrically. The 90% confidence interval (CI) of the ratios (teat/reference) of log-transformed AUC0-t and Cmax fell within the bioequivalence acceptance range of 80-125%. The results showed that the 90% CI of the ratios of AUC0-t and Cmax were 105.1% (101.0-109.4%) and 92.4% (82.5-103.4%), respectively, which therefore could conclude 2 oral cefaclor capsule formulations of cefaclor are bioequivalent. Both treatments showed similar tolerability and safety. |
| Databáze: | OpenAIRE |
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