Comparative bioavailability and bioequivalence of two 400 mg moxifloxacin tablet products after single dose administration in healthy volunteers under fasting conditions
Abstract
The aim of this study was to assess whether the pharmacokinetic profiles of two Moxifloxacin formulations were similar. Moxifloxacin is a fluoroquinolone antibacterial agent with a broad spectrum of activity, encompassing Gram-negative and Gram-positive bacteria. This was a randomized, 2 sequences and 2 periods, crossover comparative study of two medications: Avalox® 400mg coated tablet, manufactured by Bayer S.A (reference), and Moxifloxacin 400mg coated tablet, manufactured by Eurofarma Laboratórios S.A (test). Plasma samples obtained from 36 eligible subjects were analyzed for Moxifloxacin using LC-MS/MS as analytical method and Moxifloxacin-d4 as internal standard. The statistical analysis showed no significant differences for AUC0-t (Avalox® vs. Moxifloxacin Eurofarma test CI [94.25 – 99.28]) and Cmax (Avalox® vs. Moxifloxacin Eurofarma test CI [90.70 – 106.45]). The current pharmacokinetic study demonstrated bioequivalence between the single agents and provided evidence of bioequivalence between Avalox® and Moxifloxacin Eurofarma.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 36 participants or records.
Read the paper
Related studies
- Structural and topological analysis of thiosemicarbazone-based metal complexes: computational and experimental study of bacterial biofilm inhibition and antioxidant activity
- Toward better cures for Mycobacterium abscessus lung disease
- Challenges for global antibiotic regimen planning and establishing antimicrobial resistance targets: implications for the WHO Essential Medicines List and AWaRe antibiotic book dosing
- Design, Synthesis and In vitro Antitubercular Effect of New Chalcone Derivatives Coupled with 1,2,3‐Triazoles: A Computational Docking Techniques
- Upregulation of pmrA, pmrB, pmrC, phoQ, phoP, and arnT genes contributing to resistance to colistin in superbug Klebsiella pneumoniae isolates from human clinical samples in Tehran, Iran
- Whole-genome sequencing of clinical isolates of Citrobacter Europaeus in China carrying blaOXA−48 and blaNDM−1
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.