Comparative Bioequivalence Study of 2 Fixed-Dose Combinations of Vildagliptin and Metformin at a Tablet Strength of 50/1000 mg in Moroccan Volunteers.

This study evaluates the bioequivalence of 2 fixed-dose combinations of vildagliptin (50 mg) and metformin (1000 mg) in healthy Moroccan volunteers. A single-dose, randomized, simple-blind, 2-sequence, 2-period crossover design was conducted with 30 participants, 28 of whom completed the study. The test product was compared to the reference product (by measuring pharmacokinetic parameters, including maximum plasma concentration, area under the concentration-time curve (AUC) from time zero to the last measurable time point, AUC from time zero extrapolated to infinity, and time to maximum concentration.

Advancing Bioanalytical Method Validation: A Comprehensive ICH M10 Approach for Validating LC-MS/MS to Quantify Fluoxetine in Human Plasma and Its Application in Pharmacokinetic Studies.

A fast and sample cleanup approach for fluoxetine in human plasma was developed using protein precipitation coupled with LC-MS-MS. Samples were treated with methanol prior to LC-MS-MS analysis. Chromatographic separation was performed on a reverse phase column with an isocratic mobile phase of methanol and 10 mM ammonium formate pH acidified with formic acid (80:20, /) at a flow rate of 0.

Comparative Bioequivalence Study of 2 Clopidogrel 75-mg Tablet Formulations in Moroccan Volunteers.

This study investigates the pharmacokinetic properties and bioequivalence of 2 formulations of clopidogrel tablets administered to a cohort of healthy Moroccan male volunteers. The primary objective was to assess the rate and extent of drug absorption from the test formulation in comparison to a reference formulation, focusing on critical parameters including maximum plasma concentration (C), area under the concentration-time curve from 0 to the last measurable time (AUC), and area under the concentration-time curve extrapolated to infinity (AUC). The results revealed that the geometric mean ratios of C, AUC, and AUC for the test formulation relative to the reference formulation were 105.