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Safety and pharmacokinetic profile of fixed-dose ivermectin with an innovative 18mg tablet in healthy adult volunteers

Author

Listed:
  • Jose Muñoz
  • Maria Rosa Ballester
  • Rosa Maria Antonijoan
  • Ignasi Gich
  • Montse Rodríguez
  • Enrico Colli
  • Silvia Gold
  • Alejandro J Krolewiecki

Abstract

Trial registration: ClinicalTrials.gov NCT03173742. Author summary: Current efforts for the control of poverty-related diseases provide drug treatments through mass drug administration (MDA) as a key component. Ivermectin is an antiparasitary drug which has been used to fight some of these diseases, and millions of treatments have been distributed with a favorable toxicity profile. The dosing strategy of ivermectin is based on weight, which in view of the safety characteristics of ivermectin might not be necessary, while a fix dosing strategy might improve logistics and access to the drug to those who need it. This study was conducted in healthy adult volunteers in which we compared 3 treatment regimens: the weight-based reference standard versus 2 experimental regimens of fix-dose 18 and 36 mg using 18 mg tablets. All 54 volunteers received the 3 treatments sequentially. The results confirmed that the fixed-dose regimen (both 18 mg and 36 mg) are as safe as the standard dosage and could justify the use of fix dosing regimens rather than the current weight based strategy.

Suggested Citation

  • Jose Muñoz & Maria Rosa Ballester & Rosa Maria Antonijoan & Ignasi Gich & Montse Rodríguez & Enrico Colli & Silvia Gold & Alejandro J Krolewiecki, 2018. "Safety and pharmacokinetic profile of fixed-dose ivermectin with an innovative 18mg tablet in healthy adult volunteers," PLOS Neglected Tropical Diseases, Public Library of Science, vol. 12(1), pages 1-16, January.
    • Handle: RePEc:plo:pntd00:0006020
    DOI: 10.1371/journal.pntd.0006020
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