NDLI: Bioequivalence evaluation of cefdinir in healthy fasting subjects.

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Bioequivalence evaluation of cefdinir in healthy fasting subjects.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Chen, J. Jiang, B. Lou, H. Yu, L. Ruan, Z.
Description	Author Affiliation: Chen J ( School of Medicine, Zhejiang University, Hangzhou, People's Republic of China.)
Abstract	A simple and sensitive HPLC method was developed to determine cefdinir (CAS 91832-40-5) in human plasma. The method was validated by investigating the accuracy and precision for intra- and inter-day runs in a linear concentration from 0.05-2.0 µg/ml. The object of this study was to compare the bioavailability of cefdinir capsule (reference) and cefdinir granule (test) containing 100 mg of cefdinir. A randomized, open-label, single-dose, 2-way crossover bioequivalence study in 20 healthy, Chinese, male subjects was conducted. A 1-week wash-out period was applied. Blood samples were collected before and with 10 h after drug administration. The formulations were compared using the following pharmacokinetic parameters: AUC0-t, AUC0-∞ and C max. The 90% confidence interval (CI) of the ratios of log-transformed AUC0-t and AUC0-∞ were used to assess bioequivalence between the 2 formulations using the equivalence interval of 80 and 125%. The results showed that the 90% CI of the ratios of AUC0-t, AUC0-∞ and C max were 102.5% (94.7-111.0%), 103.4% (94.8-112.7%) and 106.4% (97.0-116.7%), respectively, which indicated 2 formulations of cefidinir are bioequivalent. Both treatments showed similar tolerability and safety.
File Format	HTM / HTML
ISSN	21949379
Issue Number	1
Volume Number	62
e-ISSN	21949387
Journal	Arzneimittelforschung
Language	English
Publisher	Thieme
Publisher Date	2012-01-01
Publisher Place	Germany
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Anti-bacterial Agents Pharmacokinetics Cephalosporins Fasting Metabolism Adult Area Under Curve Chromatography, High Pressure Liquid Cross-over Studies Humans Male Quality Control Therapeutic Equivalency Journal Article Randomized Controlled Trial
Content Type	Text
Resource Type	Article
Subject	Medicine Drug Discovery

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