Comparative bioavailability and bioequivalence of two 400 mg moxifloxacin tablet products after single dose administration in healthy volunteers under fasting conditions
DOI:
https://doi.org/10.34119/bjhrv7n1-381Keywords:
moxifloxacin, pharmacokinetics, antibacterial, therapeutic equivalence, bioequivalence, HPLC-MS/MSAbstract
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.
References
Keating GM, Scott LJ. Moxifloxacin: a review of its use in the management of bacterial infections. Drugs. 2004;64(20):2347-77.
Biedenbach DJ, Barrett MS, Croco MA, Jones RN. BAY 12-8039, a novel fluoroquinolone. Activity against important respiratory tract pathogens. Diagn Microbiol Infect Dis. 1998;32(1):45-50.
PubChem [Internet]. Bethesda (MD): National Library of Medicine (US) NCfBI. PubChem Compound Summary for CID 152946, Moxifloxacin 2004 [Available from: https://pubchem.ncbi.nlm.nih.gov/compound/152946.
Sadeek SA, El-Shwiniy WH, El-Attar MS. Synthesis, characterization and antimicrobial investigation of some moxifloxacin metal complexes. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2011;84(1):99-110.
Naidoo A, Naidoo K, McIlleron H, Essack S, Padayatchi N. A Review of Moxifloxacin for the Treatment of Drug-Susceptible Tuberculosis. J Clin Pharmacol. 2017;57(11):1369-86.
Stass H, Dalhoff A, Kubitza D, Schühly U. Pharmacokinetics, safety, and tolerability of ascending single doses of moxifloxacin, a new 8-methoxy quinolone, administered to healthy subjects. Antimicrob Agents Chemother. 1998;42(8):2060-5.
Barrett JF, Macielag MJ, Fernandez J, Hlasta DJ. Meeting Highlights Anti-infectives: 36th Interscience Conference on Antimicrobial Agents and Chemotherapy New Orleans, Louisiana, USA, September 15 – 18, 1996. Expert Opinion on Investigational Drugs. 1996;5(11):1533-48.
Pfaller M. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy. 1996.
Stass H, Kubitza D, Schüly V, Wingendes W, editors. Pharmacokinetics, safety, and tolerability of 800 mg BAY 12-8039 administered orally as a single dose. Program and abstracts of the 8th European Congress of Microbiology and Infectious Diseases, Lausanne, Switzerland; 1997.
Lubasch A, Keller I, Borner K, Koeppe P, Lode H. Comparative pharmacokinetics of ciprofloxacin, gatifloxacin, grepafloxacin, levofloxacin, trovafloxacin, and moxifloxacin after single oral administration in healthy volunteers. Antimicrob Agents Chemother. 2000;44(10):2600-3.
Ballow C, Lettieri J, Agarwal V, Liu P, Stass H, Sullivan JT. Absolute bioavailability of moxifloxacin. Clinical Therapeutics. 1999;21(3):513-22.
Moise PA, Birmingham MC, Schentag JJ. Pharmacokinetics and metabolism of moxifloxacin. Drugs Today (Barc). 2000;36(4):229-44.
Guimaraes CL, Galvinas PAR, Baratta JA, Pinto GA, Brandão AH, Sverdloff C. Pharmacokinetic analysis and bioequivalence of Finasteride and Doxazosin formulated in a single tablet in comparison with the corresponding single agents. Brazilian Journal of Health Review. 2023;6(3):8649-61.
Santos AFd, Francisco QAdS, Correa CEM, Marques VBB. Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios. Brazilian Journal of Health Review. 2019;2(5):4371-85.
Morais DC, Fernandes CCR, Pan TA, Silva MOd, Zung SP, Bellorio KB. Bioequivalência entre duas formulações de bromidrato de galantamina / Bioequivalence between two formulations of galantamine hydrobromide. Brazilian Journal of Health Review. 2020;3(5):11473-83.
Amran A, Tan CY, Tan KL, Ho RM, Anand AK, Leong CW. Pharmacokinetics and Bioequivalence Study of a New Branded Generic Moxifloxacin Tablet Among Healthy Volunteers. Clin Pharmacol Drug Dev. 2021;10(12):1514-8.
Tothfalusi L, Endrenyi L. Estimation of Cmax and Tmax in populations after single and multiple drug administrations. J Pharmacokinet Pharmacodyn. 2003;30(5):363-85.
Kübler J. Design and analysis of bioavailability and bioequivalence studies, 2nd edn. Shein-Chung Chow and Jen-Pei Liu, Marcel Dekker, New York, 2000. No. of pages: x+519. Price: $195.00. ISBN 0-8247-7572-4. Statistics in Medicine. 2001;20(11):1722-3.
