The Effect of Moderate- and High-Fat Meals on the Bioavailability of Dolutegravir/Rilpivirine Fixed-Dose Combination Tablet

The Effect of Moderate- and High-Fat Meals on the Bioavailability of Dolutegravir/Rilpivirine Fixed-Dose Combination Tablet

Rashmi Mehta,1 Joseph Piscitelli,2 Allen Wolstenholme,3 Caifeng Fu,4 Herta Crauwels,5 Brian Wynne,6 Kimberly Adkison7 1GlaxoSmithKline, Research Triangle Park, NC, USA; 2UNC Eshelman School of Pharmacy, Chapel Hill, NC, USA; 3GlaxoSmithKline, Collegeville, PA, USA; 4PAREXEL International, Durham, NC...

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Autores principales: Mehta R, Piscitelli J, Wolstenholme A, Fu C, Crauwels H, Wynne B, Adkison K
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2020
Materias:
food effect
pharmacokinetics
dolutegravir
rilpivirine
Therapeutics. Pharmacology
RM1-950
Acceso en línea:https://doaj.org/article/3bb1d2a687124eebbb4a17ee581f2f9d
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spelling oai:doaj.org-article:3bb1d2a687124eebbb4a17ee581f2f9d2021-12-02T10:49:39ZThe Effect of Moderate- and High-Fat Meals on the Bioavailability of Dolutegravir/Rilpivirine Fixed-Dose Combination Tablet1179-1438https://doaj.org/article/3bb1d2a687124eebbb4a17ee581f2f9d2020-06-01T00:00:00Zhttps://www.dovepress.com/the-effect-of-moderate--and-high-fat-meals-on-the-bioavailability-of-d-peer-reviewed-article-CPAAhttps://doaj.org/toc/1179-1438Rashmi Mehta,1 Joseph Piscitelli,2 Allen Wolstenholme,3 Caifeng Fu,4 Herta Crauwels,5 Brian Wynne,6 Kimberly Adkison7 1GlaxoSmithKline, Research Triangle Park, NC, USA; 2UNC Eshelman School of Pharmacy, Chapel Hill, NC, USA; 3GlaxoSmithKline, Collegeville, PA, USA; 4PAREXEL International, Durham, NC, USA; 5Janssen Pharmaceutical Companies, Beerse, Belgium; 6ViiV Healthcare, Collegeville, PA, USA; 7ViiV Healthcare, Research Triangle Park, NC, USACorrespondence: Kimberly AdkisonViiV Healthcare, 5 Moore Drive, Research Triangle Park, NC 27709, USATel +1 919 483-5867Email kim.k.adkison@viivhealthcare.comAbstract: Dolutegravir 50 mg (DTG) and rilpivirine 25 mg (RPV) are a newly approved 2-drug regimen for the treatment of HIV in virally suppressed patients. A 2-part study evaluated the relative bioavailability and food effect of five experimental fixed-dose combination (FDC) tablet formulations of DTG/RPV. When given with a moderate- or high-fat meal, the absorption of both DTG and RPV was increased, resulting in higher exposures. As per product labelling, DTG/RPV FDC should be taken with a meal.Keywords: food effect, pharmacokinetics, dolutegravir, rilpivirineMehta RPiscitelli JWolstenholme AFu CCrauwels HWynne BAdkison KDove Medical Pressarticlefood effectpharmacokineticsdolutegravirrilpivirineTherapeutics. PharmacologyRM1-950ENClinical Pharmacology: Advances and Applications, Vol Volume 12, Pp 49-52 (2020)
institution DOAJ
collection DOAJ
language EN
topic food effect
pharmacokinetics
dolutegravir
rilpivirine
Therapeutics. Pharmacology
RM1-950
spellingShingle food effect
pharmacokinetics
dolutegravir
rilpivirine
Therapeutics. Pharmacology
RM1-950
Mehta R
Piscitelli J
Wolstenholme A
Fu C
Crauwels H
Wynne B
Adkison K
The Effect of Moderate- and High-Fat Meals on the Bioavailability of Dolutegravir/Rilpivirine Fixed-Dose Combination Tablet
description Rashmi Mehta,1 Joseph Piscitelli,2 Allen Wolstenholme,3 Caifeng Fu,4 Herta Crauwels,5 Brian Wynne,6 Kimberly Adkison7 1GlaxoSmithKline, Research Triangle Park, NC, USA; 2UNC Eshelman School of Pharmacy, Chapel Hill, NC, USA; 3GlaxoSmithKline, Collegeville, PA, USA; 4PAREXEL International, Durham, NC, USA; 5Janssen Pharmaceutical Companies, Beerse, Belgium; 6ViiV Healthcare, Collegeville, PA, USA; 7ViiV Healthcare, Research Triangle Park, NC, USACorrespondence: Kimberly AdkisonViiV Healthcare, 5 Moore Drive, Research Triangle Park, NC 27709, USATel +1 919 483-5867Email kim.k.adkison@viivhealthcare.comAbstract: Dolutegravir 50 mg (DTG) and rilpivirine 25 mg (RPV) are a newly approved 2-drug regimen for the treatment of HIV in virally suppressed patients. A 2-part study evaluated the relative bioavailability and food effect of five experimental fixed-dose combination (FDC) tablet formulations of DTG/RPV. When given with a moderate- or high-fat meal, the absorption of both DTG and RPV was increased, resulting in higher exposures. As per product labelling, DTG/RPV FDC should be taken with a meal.Keywords: food effect, pharmacokinetics, dolutegravir, rilpivirine
format article
author Mehta R
Piscitelli J
Wolstenholme A
Fu C
Crauwels H
Wynne B
Adkison K
author_facet Mehta R
Piscitelli J
Wolstenholme A
Fu C
Crauwels H
Wynne B
Adkison K
author_sort Mehta R
title The Effect of Moderate- and High-Fat Meals on the Bioavailability of Dolutegravir/Rilpivirine Fixed-Dose Combination Tablet
title_short The Effect of Moderate- and High-Fat Meals on the Bioavailability of Dolutegravir/Rilpivirine Fixed-Dose Combination Tablet
title_full The Effect of Moderate- and High-Fat Meals on the Bioavailability of Dolutegravir/Rilpivirine Fixed-Dose Combination Tablet
title_fullStr The Effect of Moderate- and High-Fat Meals on the Bioavailability of Dolutegravir/Rilpivirine Fixed-Dose Combination Tablet
title_full_unstemmed The Effect of Moderate- and High-Fat Meals on the Bioavailability of Dolutegravir/Rilpivirine Fixed-Dose Combination Tablet
title_sort effect of moderate- and high-fat meals on the bioavailability of dolutegravir/rilpivirine fixed-dose combination tablet
publisher Dove Medical Press
publishDate 2020
url https://doaj.org/article/3bb1d2a687124eebbb4a17ee581f2f9d
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