Comparative safety, tolerance, and pharmacokinetics of amphotericin B lipid complex and amphotericin B desoxycholate in healthy male volunteers

V. L. Kan, J. E. Bennett, M. A. Amantea, M. C. Smolskis, E. McManus, D. M. Grasela, J. W. Sherman

Research output: Contribution to journalReview articlepeer-review

Abstract

Amphotericin B lipid complex (ABLC), a lipid complex formulation of amphotericin B, and amphotencin B desoxycholate (AB) were compared for safety, tolerance, and pharmacokinetics in two groups of eight healthy male volunteers. After a 1-mg test dose, study drug was infused at 0.1, 0.25, and 0.5 mg/kg; the 0.5-mg/kg dose was not given to subjects receiving AB ABLC caused few acute adverse effects except for mild somnolence (drowsiness) in six volunteers. In addition, three of eight ABLC recipients had asymptomatic, transient serum transaminase elevations that resolved spontaneously. The AB recipients experienced more acute side effects but only one had a mild shaking chill; three of eight also experienced sleepiness. No significant changes in vital signs, electrocardiograms, oximetry, pulmonary function, or clinical status were observed in either group. Due to its increased estimated volume of distribution and estimated clearance, ABLC yielded decreased amphotericin B levels and area under the serum concentration versus time curve relative to AB.

Original languageEnglish (US)
Pages (from-to)418-421
Number of pages4
JournalJournal of Infectious Diseases
Volume164
Issue number2
DOIs
StatePublished - Aug 1991

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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