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
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 (Cmax), and Area Under the Curve from zero to 24 h (AUC0-24 h). The 90% CIs of the geometric means of the T/R ratios for Cmax and AUC0-24 h for metformin were 92.01-102.66% and 93.55-101.80%, respectively; the corresponding results for vildagliptin were 96.03-107.09% and 94.46-101.92%, respectively. Other parameters, such as AUC0-∞, time to maximum concentration (Tmax), and terminal half-life (t1/2), were comparable between the test and reference products. Adverse events (AEs), mainly…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 18 participants or records.
Read the paper
Related studies
- Metformin as an adjuvant in breast cancer treatment
- Metformin Lysosomal Targeting: A Novel Aspect to Be Investigated for Metformin Repurposing in Neurodegenerative Diseases?
- Aberrant HSF1 signaling activation underlies metformin amelioration of myocardial infarction in mice
- Metformin induces ZFP36 by mTORC1 inhibition in cervical cancer-derived cell lines
- Protein Interaction Network for Identifying Vascular Response of Metformin (Oral Antidiabetic)
- Preventing Long COVID With Metformin
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.