Open-Label Crossover Oral Bioequivalence Pharmacokinetics Comparison for a 3-Day Loading Dose Regimen and 15-Day Steady-State Administration of SUBA-Itraconazole and Conventional Itraconazole Capsules in Healthy Adults-Reference-Cited by-同舟云学术

Open-Label Crossover Oral Bioequivalence Pharmacokinetics Comparison for a 3-Day Loading Dose Regimen and 15-Day Steady-State Administration of SUBA-Itraconazole and Conventional Itraconazole Capsules in Healthy Adults

Published:2020-07-22 Issue:8 Volume:64 Page:
ISSN:0066-4804
Container-title:Antimicrobial Agents and Chemotherapy
language:en
Short-container-title:Antimicrob Agents Chemother

Author:

Thompson George R.¹²,Lewis Phoebe³,Mudge Stuart⁴,Patterson Thomas F.⁵⁶,Burnett Bruce P.³

Affiliation:

1. UC Davis School of Medicine, Department of Internal Medicine, Division of Infectious Diseases, Sacramento, California, USA

2. UC Davis School of Medicine, Department of Medical Microbiology and Immunology, Sacramento, California, USA

3. Department of Medical Affairs, Mayne Pharma, Inc., Raleigh, North Carolina, USA

4. Department of Medical Affairs, Mayne Pharma, LLC, Melbourne, Australia

5. University of Texas Health Science Center, Division of Infectious Diseases, San Antonio, Texas, USA

6. South Texas Veterans Health Care System, San Antonio, Texas, USA

Abstract

Super bioavailability (SUBA) itraconazole (S-ITZ), which releases drug in the duodenum, and conventional itraconazole (C-ITZ), which releases drug in the stomach, were compared in two pharmacokinetic (PK) studies: a 3-day loading dose study and a 15-day steady-state administration study. These were crossover oral bioequivalence studies performed under fed conditions in healthy adult volunteers. In the loading dose study, C-ITZ (two doses of 100 mg each) and S-ITZ (two doses of 65 mg each) were administered three times daily for 3 days and once on day 4 ( n = 15).

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Link

https://journals.asm.org/doi/pdf/10.1128/AAC.00400-20

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