Trial reportScientific reports2026
Bioequivalence assessment between two formulations of a film-coated fixed-dose combination of metformin and vildagliptin (850/50mg) in healthy Tunisian subjects under fed conditions.
Trial report in Scientific reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In Tunisia, bioequivalence studies have been required for generic drug approval since 2008. This study aimed to assess the bioequivalence of vildagliptin and metformin fixed-dose combination (FDC) 850/50 mg for a tested (Bi-Galvine) versus the approved reference products (Galvumet). A randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study with a washout period of 7 days to compare metformin/vildagliptin film-coated tablets in 18 healthy Tunisian subjects aged between 18 and 50 years under fed conditions was conducted at the National Center Chalbi Belkahia of Pharmacovigilance. During each period, 20 blood samples were collected from each subject at pre-dosing (0.00) and between 0.25 and 24.00 h after dosing. The bioequivalence between the test (T) and reference (R) products required 90% confidence intervals (CIs) for the geometric least square (LS) mean T/R ratio to be within 80-125% for the pharmacokinetic parameters, maximum plasma concentration (C
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