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Randomized Controlled Trial
. 2025 Jun;398(6):6821-6829.
doi: 10.1007/s00210-024-03701-8. Epub 2024 Dec 16.

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

Nan Mao #  1 , Zuoheng Xu #  1 , Jianfen Su  1   2 , Bingna Wang  1   2 , Jiajing Xia  3 , Diqun Zheng  4 , Jianxing Liao  4 , Xiaoyan Liu  5
Affiliations
Randomized Controlled Trial

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

Nan Mao et al. Naunyn Schmiedebergs Arch Pharmacol. 2025 Jun.

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 Cmax, AUC0-t and AUC0-∞ 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).

Keywords: Bioequivalence; Cefdinir dispersible tablets; Healthy Chinese volunteers; Pharmacokinetics; Safety.

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Conflict of interest statement

Declarations. Ethics approval: This clinical trial was registered in the China Drug Trials Registry ( http://www.chinadrugtrials.org.cn ; registration number: CTR20210441; registration date: March 11, 2021). It was approved by the Ethics Committee of Panyu Central Hospital (Clinical Research Ethics Committee approval number: PYZXYYEC【2020–029】) and was conducted independently at the Phase I Clinical Trial Research Center of Panyu Central Hospital from March 15, 2021, to April 12, 2021. This study complied with the requirements of the Declaration of Helsinki (1989), Guidelines of Good Clinical Practice, and other related guiding principles. Consent to participate: Informed consent was obtained from all individual participants included in the trial. Consent for publication: There are no identifying details in this manuscript. Competing interests: The authors declare no competing interests.

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