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Purpose <p>While imeglimin’s, oral antidiabetic agent, efficacy and safety are established in Japanese and Western populations, pharmacokinetic data from Middle Eastern and African cohorts remain limited. This study aimed to evaluate the bioequivalence of test and reference imeglimin formulations under fasting conditions in healthy Egyptian adults.</p> Methods <p>In a randomized, open-label, two-period, two-sequence crossover trial, healthy male and female adults received a single 500 mg oral dose of either formulation under fasting conditions, separated by a one-week washout. Adverse events (AEs) were assessed via direct questioning, participants’ reporting, vital signs monitoring, and clinical laboratory evaluations. Plasma concentrations were measured up to 72 h post-dose, and pharmacokinetic parameters were derived using non-compartmental analysis. Bioequivalence was concluded if the geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for peak plasma concentration (C<sub>max</sub>), area under the concentration–time curve to 72 h (AUC<sub>0-72</sub>), and to infinity (AUC<sub>0–inf</sub>) were within 80–125%.</p> Results <p>In 29 healthy participants, all pharmacokinetic endpoints met bioequivalence criteria. GMR (90% CI) for each pharmacokinetic endpoint were: C<sub>max</sub> 101.75% (94.42–109.64); AUC<sub>0–72</sub> 100.66% (94.28–107.46); AUC<sub>0–inf</sub> 100.13% (93.77–106.92). The intrasubject variability was low (14–17%). Both formulations were well tolerated, with only mild transient adverse events (headache, abdominal pain) and no serious events.</p> Conclusion <p>The test formulation of imeglimin was bioequivalent to the reference, with a favorable safety profile. This first pharmacokinetic and bioequivalence study in a Middle Eastern/African population supports regulatory approval and enhances opportunities for affordable access to imeglimin in type 2 diabetes management.</p> <p>Clinical trial number.</p> <p>The ClinicalTrials.gov registration number is NCT07127094, retrospectively registered on August 15, 2025.</p> Graphical Abstract <p></p>

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Bioequivalence assessment of imeglimin hydrochloride tablet, a novel glimin-class antidiabetic agent

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月26日

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  • Mamdouh R. Rezk,
  • Kamal A. Badr,
  • Ahmed Abd El Hamid Hosny,
  • Aya M. AbdelMagid

摘要

Purpose

While imeglimin’s, oral antidiabetic agent, efficacy and safety are established in Japanese and Western populations, pharmacokinetic data from Middle Eastern and African cohorts remain limited. This study aimed to evaluate the bioequivalence of test and reference imeglimin formulations under fasting conditions in healthy Egyptian adults.

Methods

In a randomized, open-label, two-period, two-sequence crossover trial, healthy male and female adults received a single 500 mg oral dose of either formulation under fasting conditions, separated by a one-week washout. Adverse events (AEs) were assessed via direct questioning, participants’ reporting, vital signs monitoring, and clinical laboratory evaluations. Plasma concentrations were measured up to 72 h post-dose, and pharmacokinetic parameters were derived using non-compartmental analysis. Bioequivalence was concluded if the geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for peak plasma concentration (Cmax), area under the concentration–time curve to 72 h (AUC0-72), and to infinity (AUC0–inf) were within 80–125%.

Results

In 29 healthy participants, all pharmacokinetic endpoints met bioequivalence criteria. GMR (90% CI) for each pharmacokinetic endpoint were: Cmax 101.75% (94.42–109.64); AUC0–72 100.66% (94.28–107.46); AUC0–inf 100.13% (93.77–106.92). The intrasubject variability was low (14–17%). Both formulations were well tolerated, with only mild transient adverse events (headache, abdominal pain) and no serious events.

Conclusion

The test formulation of imeglimin was bioequivalent to the reference, with a favorable safety profile. This first pharmacokinetic and bioequivalence study in a Middle Eastern/African population supports regulatory approval and enhances opportunities for affordable access to imeglimin in type 2 diabetes management.

Clinical trial number.

The ClinicalTrials.gov registration number is NCT07127094, retrospectively registered on August 15, 2025.

Graphical Abstract