生物学的同等性とバイオアベイラビリティのジャーナル

概要

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

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.