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The Effect of Food on the Absorption of Abiraterone Acetate from a Fine Particle Dosage Form: A Randomized Crossover Trial in Healthy Volunteers

The Effect of Food on the Absorption of Abiraterone Acetate from a Fine Particle Dosage Form: A... Oncol Ther (2017) 5:161–170 DOI 10.1007/s40487-017-0054-2 ORIGINAL RESEARCH The Effect of Food on the Absorption of Abiraterone Acetate from a Fine Particle Dosage Form: A Randomized Crossover Trial in Healthy Volunteers . . . Alexander Papangelou Anthony J. Olszanski Cy Aaron Stein Bill Bosch Paul Nemeth Received: August 17, 2017 / Published online: November 15, 2017 The Author(s) 2017. This article is an open access publication bioequivalent to OAA 1000 mg when taken in ABSTRACT fasted conditions. Methods: Healthy male subjects (N = 25) fasted Introduction: Abiraterone acetate (AA) is 10 h overnight before randomization in a approved for treatment of metastatic castra- crossover design received a single 500-mg dose tion-resistant prostate cancer. The originator AA of AAFP under fasted or fed conditions. (OAA) formulation has been associated with Results: The extent of AAFP drug exposure was AUC and C increases of 10- and 17-fold, max significantly (P\0.001) greater under fed versus respectively, when administered following a fasted conditions. Following a single dose of high-fat meal relative to the fasted state. AA fine AAFP, relative bioavailability measured by the particle (AAFP) is a proprietary formulation geometric mean ratio of AUC and C of abi- max (utilizing SoluMatrix Fine Particle http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Oncology and Therapy Springer Journals

The Effect of Food on the Absorption of Abiraterone Acetate from a Fine Particle Dosage Form: A Randomized Crossover Trial in Healthy Volunteers

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Publisher
Springer Journals
Copyright
Copyright © 2017 by Springer Healthcare Ltd.
Subject
Medicine & Public Health; Internal Medicine
ISSN
2366-1070
eISSN
2366-1089
DOI
10.1007/s40487-017-0054-2
Publisher site
See Article on Publisher Site

Abstract

Oncol Ther (2017) 5:161–170 DOI 10.1007/s40487-017-0054-2 ORIGINAL RESEARCH The Effect of Food on the Absorption of Abiraterone Acetate from a Fine Particle Dosage Form: A Randomized Crossover Trial in Healthy Volunteers . . . Alexander Papangelou Anthony J. Olszanski Cy Aaron Stein Bill Bosch Paul Nemeth Received: August 17, 2017 / Published online: November 15, 2017 The Author(s) 2017. This article is an open access publication bioequivalent to OAA 1000 mg when taken in ABSTRACT fasted conditions. Methods: Healthy male subjects (N = 25) fasted Introduction: Abiraterone acetate (AA) is 10 h overnight before randomization in a approved for treatment of metastatic castra- crossover design received a single 500-mg dose tion-resistant prostate cancer. The originator AA of AAFP under fasted or fed conditions. (OAA) formulation has been associated with Results: The extent of AAFP drug exposure was AUC and C increases of 10- and 17-fold, max significantly (P\0.001) greater under fed versus respectively, when administered following a fasted conditions. Following a single dose of high-fat meal relative to the fasted state. AA fine AAFP, relative bioavailability measured by the particle (AAFP) is a proprietary formulation geometric mean ratio of AUC and C of abi- max (utilizing SoluMatrix Fine Particle

Journal

Oncology and Therapy – Springer Journals

Published: Nov 15, 2017

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