生物学的同等性とバイオアベイラビリティのジャーナル

概要

Bioavailability of Two Tablet Formulations of a Single Dose of Moxifloxacin 400 mg: An Open-Label, Randomized, Two-Period Crossover Comparison in Healthy Mexican Adult Volunteers

Gabriel Mendoza- Tamayo, Alejandra Rosete- Reyes, Roberto Medina- Santillán, Jessica González- Bañuelos, Clara Espinosa- Martínez, Victoria Burke- Fraga and Mario González-de la Parra

Moxifloxacin is a synthetic fluoroquinolone with a broad spectrum of antibacterial activity. It is indicated for the treatment of respiratory tract, skin and intra-abdominal infections. The aim of this study was to compare the bioavailability and to determine the bioequivalence of a test and reference formulation of oral moxifloxacin 400 mg, administered as a tablet, and to generate data regarding the oral bioavailability of this drug in Mexican population. This single-dose, randomized-sequence, open-label, two-period, crossover study was conducted on a total of 26 healthy Mexican adult subjects of both genders, with an eight-day washout period. Study formulations were administered after a 10-hour overnight fast. For pharmacokinetic analysis, blood samples were drawn at 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48 and 72 hours after administration. Plasma concentrations of moxifloxacin were determined using HPLC coupled with a fluorescence detector. The test and reference formulations were considered bioequivalent if the 90% CIs for the geometric mean test/reference ratios were within a predetermined range of 80% to 125%. The 90% CIs for the geometric mean ratios of Cmax, AUC0–t and AUC0–∞were 88.67% to 108.70%, 97.44% to 102.50%, and 97.70% to 104.82 %, respectively. In this study a single dose of the test formulation met the regulatory requirements for assuming bioequivalence, based on the rate and extent of absorption.