Arzneimittelforschung 2008; 58(3): 149-153
DOI: 10.1055/s-0031-1296485
Antibiotics · Antimycotics · Antiviral Drugs · Chemotherapeutics · Cytostatics
Editio Cantor Verlag Aulendorf (Germany)

Comparative Bioavailability of Two Cefdinir Suspension Formulations in Middle Eastern Healthy Volunteers after Single Oral Administration

Zaid Naser Abdel
1   College of Pharmacy, An-Najah National University, Nablus, Palestine
,
Alhaique Franco
1   Faculty of Pharmacy, University “La Sapienza”, Rome, Italy
,
Kort Jamal
1   Pharmacare Chemical & Cosmetics, Ramallah, Palestine
,
Sweileh Waleed
1   College of Pharmacy, An-Najah National University, Nablus, Palestine
› Author Affiliations
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Publication History

Publication Date:
15 December 2011 (online)

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Abstract

The aim of this study was to compare the bioavailability, after oral administration, of the generic “Adcef® Suspension” (test) (125 mg/5 ml cefdinir; CAS 91832-40-5), with that of a commercially available original preparation (reference) (125 mg/5 ml cefdinir). For this purpose a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers. The Middle Eastern selected volunteers were divided into two groups of 12 subjects. One group was treated with the reference standard and the other one with the test, with a crossover after the drug washout period of 7 days. Blood samples were collected at fixed time intervals and cefdinir concentrations were determined by a validated HPLC assay method. The pharmacokinetic parameters AUC0–24, AUC0–∞, Cmax, Tmax, Ke and T1/2 were determined for both formulations and were compared statistically to evaluate the bioequivalence between the two brands of cefdinir, using the statistical model recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. Based on the statistical evaluation it was concluded that the two formulations exhibit