Trial reportNaunyn-Schmiedeberg's archives of pharmacology2026
Bioequivalence assessment of imeglimin hydrochloride tablet, a novel glimin-class antidiabetic agent.
Trial report in Naunyn-Schmiedeberg's archives of pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07127094 (Open Label, Randomized, Single-dose, Two-sequence, Two-period, Crossover Study to Assess the Bioequivalence of Imeglimin HCl in Glimcoza 500 mg Film Coated Tablet), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Open Label, Randomized, Single-dose, Two-sequence, Two-period, Crossover Study to Assess the Bioequivalence of Imeglimin HCl in Glimcoza 500 mg Film Coated Tablet (Test Product) in Comparison With Twymeeg® 500 mg Tablet (Reference Product) in Healthy Subjects Under Fasting Condition
Who cites it
2 citing papers in PubMed.
- Bioequivalence evaluation of two cariprazine hard capsule formulations.Naunyn-Schmiedeberg's archives of pharmacology · 2026Trial
- A Novel Ultra-Performance Liquid Chromatography-Electrospray Ionisation-Tandem Mass Spectrometry Method for Quantification of Imeglimin in Human Plasma: Application to a Bioequivalence Study.Analytical science advances · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeWhile 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.
methodsIn 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
resultsIn 29 healthy participants, all pharmacokinetic endpoints met bioequivalence criteria. GMR (90% CI) for each pharmacokinetic endpoint were: C
conclusionThe 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.
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