Bioequivalence of cefdinir capsules in Chinese healthy population under fasting/high-fat fed condition
10.12092/j.issn.1009-2501.2020.07.004
- VernacularTitle: 头孢地尼胶囊在中国健康人群空腹/高脂餐后给药的生物等效性研究
- Author:
Zeyu ZHANG
1
Author Information
1. Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University
- Publication Type:Journal Article
- Keywords:
Bioequivalence;
Cefdinir capsule;
Fasting/high-fat meal administration;
Pharmacokinetics
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(7):740-745
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To evaluate the bioequivalence and safety of two cefdinir capsules under a fasting/high-fat fed condition in healthy people. METHODS: Twenty-six healthy volunteers were randomized to cross-test single-dose oral cefdinir capsules or reference preparations for fasting. Thirty-six healthy volunteers were randomized to crossed single-dose oral cefdinir capsule test preparations or reference preparations after high-fat meals. The blood concentration of cefdinir was determined by liquid chromatography-mass spectrometry (LC-MS/MS). Pharmacokinetic parameters and equivalence were calculated and evaluated using WinNonlin 6.4 and SAS 9.4 software. RESULTS: The 90% confidence intervals of the geometric mean ratios of the Cmax, AUC0-t, and AUC0-∞ for the test and reference preparations of cefdinir capsules taken by twenty-five healthy volunteers for fasting were 93.01%-109.22%, 96.16%-110.06%, and 96.38%-110.16%, all at 80.00%-125.00% within the range of bioequivalence. The 90% confidence intervals of the geometric mean ratios of the Cmax, AUC0-t, and AUC0-∞ for the test and reference preparations of cefdinir capsules taken by thirty-six healthy volunteers for a high-fat fed were 93.91%-103.28%, 92.93%-100.72% and 92.97%-101.26%, all at 80.00%-125.00% within the range of bioequivalence. The incidences of adverse reactions in healthy volunteers taking cefdinir capsules for the fasting test and reference preparations were 12.0% and 11.5%, respectively. The incidence of adverse reactions in healthy volunteers taking cefdinir capsules after the meal was 25.0% and 27.8%, respectively. CONCLUSION: The test preparation of cefdinir capsules and the reference preparation are bioequivalent, and the volunteers show good safety and tolerability under the test dose.
