Study on Pharmacokinetics and Bioequivalence of Cefdinir Dispersible Tablet in Healthy Chinese Volunteers
Cai-Li Zhang, Jian-Jie Jiao,Yan-Na Wu, Jun-qiu Song,Wei-Zhen Gao, De-Lu Ma and Jian-Shi Lou*
Division of Clinical Pharmacology, Department of Pharmacology, Tianjin Medical University, Tianjin 300070, P.R.China
- *Corresponding Author:
- Prof. Jian-Shi Lou
Department of Pharmacology, Tianjin Medical University
22 Qi Xiang Tai Road, Tianjin 300070, P.R.China
Tel: 86-22 23542523;
E-mail: [email protected]
Received Date: May 19, 2011; Accepted Date: July 07, 2011; Published Date: July 09, 2011
Citation: Zhang CL, Jiao JJ, Wu YN, Song JQ, Gao WZ, et al. (2011) Study on Pharmacokinetics and Bioequivalence of Cefdinir Dispersible Tablet in Healthy Chinese Volunteers. J Bioequiv Availab 3: 114-117. doi: 10.4172/jbb.1000070
Copyright: © 2011 Zhang CL, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Aim: To evaluate the pharmacokinetics and bioequivalence of cefdinir dispersible tablet with cefdinir capsule in healthy Chinese volunteers. Methods: cefdinir dispersible tablet and cefdinir capsule were used as the test and reference preparations respectively. Two randomized, comparative two-way crossover studies were conducted in 18 healthy Chinese male volunteers. Test preparation 200mg, reference preparation 200mg were administered once orally to the volunteers fasting overnight, with 5 days washout period between the doses of the test and reference preparations. Before dosing blood sample, after dosing several blood samples were collected for a period of 12 hours. The plasma concentrations of cefdinir at different times were determined by high performance liquid chromatogrphy (HPLC) with ultraviolet (UV) assay. Pharmacokinetic parameters were calculated. Safety of the drug was evaluated. Results: The main pharmacokinetic parameters of the test and reference preparations were as follows: Cmax were 1.52±0.48μg/ml and 1.42±0.39μg/ml, T max were 3.08±0.73h and 3.22±0.81h, t 1/2 were 2.04±0.53h and 1.87±0.29h, AUC 0-t were 7.12±1.85 μg/ml•h -1 and 6.86±1.60μg/ml•h -1 AUC 0-∞ were 7.67±2.01μg/ml•h -1 and 7.38±1.85μg/ml•h -1 respectively. The relative bioavailability of test preparation was 103.53±11.50%. No significant differences between two preparations were found. The parameter mean values of the pharmacokinetic characteristics for test drug were within the bioequivalence acceptable range of 80~125% and 70~143% respectively for AUC and C max . Conclusion: The results indicate that the test preparation is bioequivalent to the reference preparation.