BIOMAT Database Logo BIOMAT Database Logo

Comparative safety, tolerance, and pharmacokinetics of amphotericin B lipid complex and amphotericin B desoxycholate in healthy male volunteers. 1991

V L Kan, and J E Bennett, and M A Amantea, and M C Smolskis, and E McManus, and D M Grasela, and J W Sherman
Clinical Mycology Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.

Amphotericin B lipid complex (ABLC), a lipid complex formulation of amphotericin B, and amphotericin 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 recipient 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, electrocardiogram, oximetry, pulmonary function, or clinical status were observed in either group. Due to its increased estimate volume of distribution and estimated clearance. ABLC yielded decreased amphotericin B levels and area under the serum concentration versus time curve relative to AB.

UI MeSH Term Description Entries
D008297 Male Males
D010092 Oximetry The determination of oxygen-hemoglobin saturation of blood either by withdrawing a sample and passing it through a classical photoelectric oximeter or by electrodes attached to some translucent part of the body like finger, earlobe, or skin fold. It includes non-invasive oxygen monitoring by pulse oximetry. Pulse Oximetry,Oximetry, Pulse,Oximetries,Oximetries, Pulse,Pulse Oximetries
D001831 Body Temperature The measure of the level of heat of a human or animal. Organ Temperature,Body Temperatures,Organ Temperatures,Temperature, Body,Temperature, Organ,Temperatures, Body,Temperatures, Organ
D004341 Drug Evaluation Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals. Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D005221 Fatigue The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli. Lassitude
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000666 Amphotericin B Macrolide antifungal antibiotic produced by Streptomyces nodosus obtained from soil of the Orinoco river region of Venezuela. Amphocil,Amphotericin,Amphotericin B Cholesterol Dispersion,Amphotericin B Colloidal Dispersion,Fungizone
D012894 Sleep Stages Periods of sleep manifested by changes in EEG activity and certain behavioral correlates; they formerly included Stage 1: sleep onset, drowsy sleep; Stage 2: light sleep; Stages 3 and 4: delta sleep, light sleep, deep sleep, telencephalic sleep. In 2007, sleep stages were redefined by The American Academy of Sleep Medicine (AASM) as: N1-N2 (sleep onset - light sleep), N3 (SLOW-WAVE SLEEP), and REM SLEEP. N1-Sleep,N2-Sleep,NREM Stage 1,NREM Stage 2,N1 Sleep,N2 Sleep,Sleep Stage,Stage, Sleep,Stages, Sleep

Related Publications

V L Kan, and J E Bennett, and M A Amantea, and M C Smolskis, and E McManus, and D M Grasela, and J W Sherman
Safety, tolerance, and pharmacokinetics of amphotericin B lipid complex in children with hepatosplenic candidiasis.
September 1997, Antimicrobial agents and chemotherapy,
V L Kan, and J E Bennett, and M A Amantea, and M C Smolskis, and E McManus, and D M Grasela, and J W Sherman
Single-dose pharmacokinetics and tolerance of a cholesteryl sulfate complex of amphotericin B administered to healthy volunteers.
June 1991, Antimicrobial agents and chemotherapy,
V L Kan, and J E Bennett, and M A Amantea, and M C Smolskis, and E McManus, and D M Grasela, and J W Sherman
Clinical pharmacokinetics and tolerance of fleroxacin in healthy male volunteers.
October 1988, The Journal of antimicrobial chemotherapy,
V L Kan, and J E Bennett, and M A Amantea, and M C Smolskis, and E McManus, and D M Grasela, and J W Sherman
In-vitro antifungal activity of liposomal nystatin in comparison with nystatin, amphotericin B cholesteryl sulphate, liposomal amphotericin B, amphotericin B lipid complex, amphotericin B desoxycholate, fluconazole and itraconazole.
September 1999, The Journal of antimicrobial chemotherapy,
V L Kan, and J E Bennett, and M A Amantea, and M C Smolskis, and E McManus, and D M Grasela, and J W Sherman
Population pharmacokinetics of amphotericin B lipid complex in neonates.
December 2005, Antimicrobial agents and chemotherapy,
V L Kan, and J E Bennett, and M A Amantea, and M C Smolskis, and E McManus, and D M Grasela, and J W Sherman
Pharmacokinetics and safety of oral almotriptan in healthy male volunteers.
October 2004, Biopharmaceutics & drug disposition,
V L Kan, and J E Bennett, and M A Amantea, and M C Smolskis, and E McManus, and D M Grasela, and J W Sherman
Pharmacokinetics and Safety of Enzalutamide in Healthy Chinese Male Volunteers.
February 2019, Clinical therapeutics,
V L Kan, and J E Bennett, and M A Amantea, and M C Smolskis, and E McManus, and D M Grasela, and J W Sherman
Comparative safety of amphotericin B lipid complex and amphotericin B deoxycholate as aerosolized antifungal prophylaxis in lung-transplant recipients.
January 2004, Transplantation,
V L Kan, and J E Bennett, and M A Amantea, and M C Smolskis, and E McManus, and D M Grasela, and J W Sherman
Nephrotoxicity of amphotericin B desoxycholate.
September 2001, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,
V L Kan, and J E Bennett, and M A Amantea, and M C Smolskis, and E McManus, and D M Grasela, and J W Sherman
Comparative in vitro antifungal activity of amphotericin B lipid complex, amphotericin B and fluconazole.
January 2000, Chemotherapy,
Copied contents to your clipboard!