Bioavailability of Single-Dose SUBA-Itraconazole Compared to Conventional Itraconazole under Fasted and Fed Conditions

被引：20

作者：

Rauseo, Adriana M. ^{[1
]}

Mazi, Patrick ^{[1
]}

Lewis, Phoebe ^{[2
]}

Burnett, Bruce ^{[2
]}

Mudge, Stuart ^{[2
]}

Spec, Andrej ^{[1
]}

机构：

[1] Washington Univ, Dept Med, Div Infect Dis, St Louis, MO 63130 USA

[2] Mayne Pharma, Med Affairs, Raleigh, NC USA

来源：

ANTIMICROBIAL AGENTS AND CHEMOTHERAPY | 2021年 / 65卷 / 08期

关键词：

itraconazole; endemic mycoses; bioavailability; pharmacokinetics; CLINICAL-PRACTICE GUIDELINES; PROPHYLAXIS; PHARMACOLOGY; SOCIETY; UPDATE; HISTOPLASMOSIS; INFECTIONS; MANAGEMENT; SAFETY; FOOD;

D O I：

10.1128/AAC.00134-21

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

Conventional itraconazole (C-ITZ) suffers from absorption variability. SUBA-itraconazole (S-ITZ) is more bioavailable than C-ITZ at steady state in a fed condition, but there are no data comparing the two under a fasted state. An open-label, singledose, randomized, bioequivalence study was performed comparing S-ITZ to C-ITZ capsules under fasted and fed conditions in healthy adults measuring itraconazole and hydroxyitraconazole plasma levels. This study demonstrated less variability of S-ITZ compared to C-ITZ capsules under fasted conditions.

引用

页数：6

共 25 条

[1] Population Pharmacokinetic Modeling of Itraconazole and Hydroxyitraconazole for Oral SUBA-Itraconazole and Sporanox Capsule Formulations in Healthy Subjects in Fed and Fasted States [J].

Abuhelwa, Ahmad Y. ;

Foster, David J. R. ;

Mudge, Stuart ;

Hayes, David ;

Upton, Richard N. .

ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2015, 59 (09) :5681-5696

[2] Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British Society for Medical Mycology [J].

Ashbee, H. Ruth ;

Barnes, Rosemary A. ;

Johnson, Elizabeth M. ;

Richardson, Malcolm D. ;

Gorton, Rebecca ;

Hope, William W. .

JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 2014, 69 (05) :1162-1176

[3] Pharmacology of systemic antifungal agents [J].

Ashley, Elizabeth S. Dodds ;

Lewis, Russell ;

Lewis, James S. ;

Martin, Craig ;

Andes, David .

CLINICAL INFECTIOUS DISEASES, 2006, 43 :S28-S39

[4] FOOD INTERACTION AND STEADY-STATE PHARMACOKINETICS OF ITRACONAZOLE CAPSULES IN HEALTHY MALE-VOLUNTEERS [J].

BARONE, JA ;

KOH, JG ;

BIERMAN, RH ;

COLAIZZI, JL ;

SWANSON, KA ;

GAFFAR, MC ;

MOSKOVITZ, BL ;

MECHLINSKI, W ;

VANDEVELDE, V .

ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 1993, 37 (04) :778-784

[5] Clinical practice guidelines for the management of blastomycosis: 2008 update by the Infectious Diseases Society of America [J].

Chapman, Stanley W. ;

Dismukes, William E. ;

Proia, Laurie A. ;

Bradsher, Robert W. ;

Pappas, Peter G. ;

Threlkeld, Michael G. ;

Kauffman, Carol A. .

CLINICAL INFECTIOUS DISEASES, 2008, 46 (12) :1801-1812

[6]

ClinicalTrials.gov, 2020, END MYC TREATM SUBA

[7] Comparison of oral fluconazole and itraconazole for progressive, nonmeningeal coccidioidomycosis - A randomized, double-blind trial [J].

Galgiani, JN ;

Catanzaro, A ;

Cloud, GA ;

Johnson, RH ;

Williams, PL ;

Mirels, LF ;

Nassar, F ;

Lutz, JE ;

Stevens, DA ;

Sharkey, PK ;

Singh, VR ;

Larsen, RA ;

Delgado, KL ;

Flanigan, C ;

Rinaldi, MG .

ANNALS OF INTERNAL MEDICINE, 2000, 133 (09) :676-686

[8]

Galgiani JN, 2016, CLIN INFECT DIS, V63, pE112, DOI 10.1093/cid/ciw360

[9] A pilot study of targeted itraconazole prophylaxis in patients with graft-versus-host disease at high risk of invasive mould infections following allogeneic stem cell transplantation [J].

Grigg, AP ;

Brown, M ;

Roberts, AW ;

Szer, J ;

Slavin, MA .

BONE MARROW TRANSPLANTATION, 2004, 34 (05) :447-453

[10] Bioequivalence approaches for highly variable drugs and drug products [J].

Haidar, Sam H. ;

Davit, Barbara ;

Chen, Mei-Ling ;

Conner, Dale ;

Lee, LaiMing ;

Li, Qian H. ;

Lionberger, Robert ;

Makhlouf, Fairouz ;

Patel, Devvrat ;

Schuirmann, Donald J. ;

Yu, Lawrence X. .

PHARMACEUTICAL RESEARCH, 2008, 25 (01) :237-241

← 1 2 3 →