CLINICAL TRIAL article
Front. Pharmacol.
Sec. Drug Metabolism and Transport
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1562692
Pharmacokinetics and bioequivalence assessment of two prucalopride formulations in healthy Chinese women: a randomized, open-label, two-period, two-sequence, self-crossover study
Provisionally accepted
- Hangzhou First People's Hospital, Hangzhou, China
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Objective: This study aimed to evaluate the pharmacokinetic bioequivalence of generic and branded prucalopride formulations. Methods: Twenty-four healthy female subjects were enrolled in both fasted and fed trials, with each subject receiving either the test(generic) or reference(branded) formulation after an overnight fast. Blood samples were collected up to 72 hours post-administration. Plasma concentrations of prucalopride were quantified using Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry (UPLC-MS) and the corresponding pharmacokinetic (PK) parameters were subsequently calculated. Clinical safety data were monitored throughout the trial period. Results: All 24 subjects completed both the fasted and fed trials. No significant differences were found in the PK data between the test and reference formulations for either the fasted or fed states. The Wilcoxon signed-rank test of Tmax revealed no significant difference between the two formulations in both fasted (p=0.319) and fed (p=0.973) states. The 90% confidence intervals (CIs) for the bioequivalence parameters fell within the 80% to 125% range, which meets the standard bioequivalence acceptance criteria.Additionally, there were no significant differences in the incidence of adverse events (AEs) between the generic and branded formulations, and no serious AEs were reported throughout the trial period.The generic and branded prucalopride tablets were bioequivalent in terms of pharmacokinetic parameters and demonstrated no clinically relevant differences in safety outcomes.
Keywords: ：Bioequivalence, Prucalopride succinate, pharmacokinetics, Healthy Chinese women, Crossover study Trial Registry
Received: 18 Jan 2025; Accepted: 24 Mar 2025.
Copyright: © 2025 Huang, Wang, Li, Shen, Tao, Zheng, Luo, Xiong, Wang and Cai. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Xiangxin Huang, Hangzhou First People's Hospital, Hangzhou, China
Ying Wang, Hangzhou First People's Hospital, Hangzhou, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.