Bioequivalence of cefdinir dispersible tablets in healthy Chinese subjects under fasting and fed conditions: a single-centred, randomized, open, single-dose, two-preparation, two-cycle, two-sequence, double-crossover trial.

Abstract

Cefdinir is a broad-spectrum antibiotic with good antibacterial activity against gram-positive and gram-negative bacteria and can be used for the treatment of various sensitive bacterial infections, such as community-acquired pneumonia, urinary tract infection and gonorrhoea. Herein, a single-centred, randomized, open, single-dose, two-preparation, two-cycle, two-sequence, double-crossover trial with a 7-day washout was conducted to investigate the pharmacokinetics, bioequivalence and safety of cefdinir dispersible tablets and the reference formulation of cefdinir capsules in healthy Chinese volunteers. Fifty-six healthy subjects were recruited and randomly assigned to the fasting and fed groups. After a single oral dose of the test or reference formulation (0.1 g), the cefdinir concentrations in the plasma were determined via HPLC-MS/MS, and pharmacokinetic parameters were obtained from the concentration‒time profiles. Overall, 24 and 31 individuals completed the evaluation under fasting and fed conditions respectively. The mean concentration‒time profiles for both formulations were similar, and the C_max, AUC_0-t and AUC_0-∞ values were entirely within the bioequivalence range of 80.00% to 125.00%. Three subjects reported 5 AEs, and 8 subjects experienced 13 AEs in the fasting and fed groups respectively, but no participants withdrew from the trial because of AEs. All adverse reactions were grade I in severity, and no serious AEs or deaths occurred. The results demonstrated that these formulations were bioequivalent in healthy Chinese subjects under fasting and fed conditions, supporting the further clinical development of cefdinir dispersible tablets. This trial was registered in the China Drug Trials Registry (registration number: CTR20210441; registration date: March 11, 2021).