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A Single‐blind, Randomized, Single‐dose, Two‐sequence, Two‐period, Crossover Study to Assess the Bioequivalence between Two Oral Tablet Formulations of Rivaroxaban 20 mg in Healthy Mexican Volunteers
The objective of this study was to demonstrate the bioequivalence of 2 oral tablet formulations of rivaroxaban 20 mg in healthy Mexican volunteers under fed conditions. This phase I, single‐blind, single‐dose, randomized, two‐sequence, two‐period crossover study included 32 volunteers. Subjects were...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9321699/ https://www.ncbi.nlm.nih.gov/pubmed/35510948 http://dx.doi.org/10.1002/cpdd.1092 |
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author | Genis‐Najera, Luis Sañudo‐Maury, Maria Elena Moquete, Trinifer |
author_facet | Genis‐Najera, Luis Sañudo‐Maury, Maria Elena Moquete, Trinifer |
author_sort | Genis‐Najera, Luis |
collection | PubMed |
description | The objective of this study was to demonstrate the bioequivalence of 2 oral tablet formulations of rivaroxaban 20 mg in healthy Mexican volunteers under fed conditions. This phase I, single‐blind, single‐dose, randomized, two‐sequence, two‐period crossover study included 32 volunteers. Subjects were randomly assigned to one of two sequences: test formulation (single 20 mg dose) in the first period followed by the reference formulation (single 20 mg dose) in the second, or vice versa. Blood samples were collected predose and at predefined timepoints across a 48‐hour period after drug intake. Rivaroxaban plasma concentrations were measured using a validated high‐performance liquid chromatography‐tandem mass spectrometry method. Pharmacokinetic parameters included maximum plasma concentration (C(max)), area under the plasma concentration‐time curve from time zero to last measurable concentration and to infinity (AUC(0‐t), AUC(0‐∞)), time to reach C(max), and half‐life. Safety was evaluated through adverse‐event monitoring using subject interviews and recording of vital signs. The 90% confidence intervals for the test/reference geometric mean ratios of C(max) (100.4%–112.7%), AUC(0‐t) (96.5%–111.6%), and AUC(0‐∞) (95.5%–109.5%) were within the bioequivalence acceptance range (80‐125%). Two adverse events (headaches) were recorded. Both formulations of rivaroxaban 20 mg tablets were bioequivalent and well tolerated in a healthy population of Mexican volunteers under fed conditions. |
format | Online Article Text |
id | pubmed-9321699 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-93216992022-07-30 A Single‐blind, Randomized, Single‐dose, Two‐sequence, Two‐period, Crossover Study to Assess the Bioequivalence between Two Oral Tablet Formulations of Rivaroxaban 20 mg in Healthy Mexican Volunteers Genis‐Najera, Luis Sañudo‐Maury, Maria Elena Moquete, Trinifer Clin Pharmacol Drug Dev Articles The objective of this study was to demonstrate the bioequivalence of 2 oral tablet formulations of rivaroxaban 20 mg in healthy Mexican volunteers under fed conditions. This phase I, single‐blind, single‐dose, randomized, two‐sequence, two‐period crossover study included 32 volunteers. Subjects were randomly assigned to one of two sequences: test formulation (single 20 mg dose) in the first period followed by the reference formulation (single 20 mg dose) in the second, or vice versa. Blood samples were collected predose and at predefined timepoints across a 48‐hour period after drug intake. Rivaroxaban plasma concentrations were measured using a validated high‐performance liquid chromatography‐tandem mass spectrometry method. Pharmacokinetic parameters included maximum plasma concentration (C(max)), area under the plasma concentration‐time curve from time zero to last measurable concentration and to infinity (AUC(0‐t), AUC(0‐∞)), time to reach C(max), and half‐life. Safety was evaluated through adverse‐event monitoring using subject interviews and recording of vital signs. The 90% confidence intervals for the test/reference geometric mean ratios of C(max) (100.4%–112.7%), AUC(0‐t) (96.5%–111.6%), and AUC(0‐∞) (95.5%–109.5%) were within the bioequivalence acceptance range (80‐125%). Two adverse events (headaches) were recorded. Both formulations of rivaroxaban 20 mg tablets were bioequivalent and well tolerated in a healthy population of Mexican volunteers under fed conditions. John Wiley and Sons Inc. 2022-05-05 2022-07 /pmc/articles/PMC9321699/ /pubmed/35510948 http://dx.doi.org/10.1002/cpdd.1092 Text en © 2022 Sanofi Aventis de México, S.A. de C.V. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Articles Genis‐Najera, Luis Sañudo‐Maury, Maria Elena Moquete, Trinifer A Single‐blind, Randomized, Single‐dose, Two‐sequence, Two‐period, Crossover Study to Assess the Bioequivalence between Two Oral Tablet Formulations of Rivaroxaban 20 mg in Healthy Mexican Volunteers |
title | A Single‐blind, Randomized, Single‐dose, Two‐sequence, Two‐period, Crossover Study to Assess the Bioequivalence between Two Oral Tablet Formulations of Rivaroxaban 20 mg in Healthy Mexican Volunteers |
title_full | A Single‐blind, Randomized, Single‐dose, Two‐sequence, Two‐period, Crossover Study to Assess the Bioequivalence between Two Oral Tablet Formulations of Rivaroxaban 20 mg in Healthy Mexican Volunteers |
title_fullStr | A Single‐blind, Randomized, Single‐dose, Two‐sequence, Two‐period, Crossover Study to Assess the Bioequivalence between Two Oral Tablet Formulations of Rivaroxaban 20 mg in Healthy Mexican Volunteers |
title_full_unstemmed | A Single‐blind, Randomized, Single‐dose, Two‐sequence, Two‐period, Crossover Study to Assess the Bioequivalence between Two Oral Tablet Formulations of Rivaroxaban 20 mg in Healthy Mexican Volunteers |
title_short | A Single‐blind, Randomized, Single‐dose, Two‐sequence, Two‐period, Crossover Study to Assess the Bioequivalence between Two Oral Tablet Formulations of Rivaroxaban 20 mg in Healthy Mexican Volunteers |
title_sort | single‐blind, randomized, single‐dose, two‐sequence, two‐period, crossover study to assess the bioequivalence between two oral tablet formulations of rivaroxaban 20 mg in healthy mexican volunteers |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9321699/ https://www.ncbi.nlm.nih.gov/pubmed/35510948 http://dx.doi.org/10.1002/cpdd.1092 |
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