Phase I Study To Evaluate the Pharmacokinetics, Safety, and Tolerability of Two Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adult Participants

Author:

Wenzler Eric1ORCID,Bleasdale Susan C.2,Sikka Monica2,Bunnell Kristen L.1ORCID,Finnemeyer Matthew3,Rosenkranz Susan L.3,Danziger Larry H.12,Rodvold Keith A.12,

Affiliation:

1. College of Pharmacy, University of Illinois at Chicago, Chicago, Illinois, USA

2. College of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA

3. Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA

Abstract

The pharmacokinetics (PK), safety, and tolerability of two repeated dosing regimens of oral fosfomycin tromethamine were evaluated in 18 healthy adult subjects. Subjects received 3 g every other day (QOD) for 3 doses and then every day (QD) for 7 doses, or vice versa, in a phase I, randomized, open-label, two-period-crossover study.

Funder

HHS | NIH | National Institute of Allergy and Infectious Diseases

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Reference26 articles.

1. . July 2007. Monurol (fosfomycin tromethamine) package insert. Forest Pharmaceuticals Inc St Louis MO. http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050717s005lbl.pdf. Accessed 11 May 2015.

2. . 2015. Fosfomycin trometamol package insert. Mercury Pharmaceuticals Limited London United Kingdom. https://www.medicines.org.uk/emc/product/7219/smpc. Accessed 30 May 2018.

3. International Clinical Practice Guidelines for the Treatment of Acute Uncomplicated Cystitis and Pyelonephritis in Women: A 2010 Update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases

4. Fosfomycin

5. Evaluation of three-dose fosfomycin tromethamine in the treatment of patients with urinary tract infections: an uncontrolled, open-label, multicentre study

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