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Fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects
Two open-label, randomized, two-period crossover studies were conducted to investigate the pharmacokinetic (PK) properties, safety, and bioequivalence of the test formulation (KD4004), a new fixed-dose combination (FDC) formulation of dapagliflozin and metformin extended release (XR) tablets, relati...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Korean Society for Clinical Pharmacology and Therapeutics
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10333646/ https://www.ncbi.nlm.nih.gov/pubmed/37440782 http://dx.doi.org/10.12793/tcp.2023.31.e10 |
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author | Lee, Hae Won Kang, Woo Youl Park, Ji Seo Lee, Jae Hwa Gwon, Mi-Ri Yang, Dong Heon Kim, Eun Hee Park, Soo-Jin Yoon, Young-Ran Seong, Sook Jin |
author_facet | Lee, Hae Won Kang, Woo Youl Park, Ji Seo Lee, Jae Hwa Gwon, Mi-Ri Yang, Dong Heon Kim, Eun Hee Park, Soo-Jin Yoon, Young-Ran Seong, Sook Jin |
author_sort | Lee, Hae Won |
collection | PubMed |
description | Two open-label, randomized, two-period crossover studies were conducted to investigate the pharmacokinetic (PK) properties, safety, and bioequivalence of the test formulation (KD4004), a new fixed-dose combination (FDC) formulation of dapagliflozin and metformin extended release (XR) tablets, relative to the reference formulation (10 mg dapagliflozin/1,000 mg metformin XR FDC tablet) in healthy subjects under fasting (Part A) and fed (Part B) conditions. After giving the dose, serial blood samples were collected for a period of 48 hours. Primary PK parameters (AUC(0-t) and C(max)) were used to assess bioequivalence between two dapagliflozin/metformin XR (10/1,000 mg) FDC formulations under fed and fasting conditions. Safety and tolerability were also evaluated. Part A and Part B were completed by 32 and 37 subjects, respectively. Bioequivalence of the two FDC formulations of dapagliflozin and metformin XR tablets was established in both the fasted and the fed conditions as the 90% confidence interval of the ratios of adjusted geometric means for AUC(0-t) and C(max) were contained within the predefined range of 0.800–1.250 bioequivalence criteria. Single-dose administration of dapagliflozin and metformin XR was safe and well tolerated as the two FDC formulations. In conclusion, both FDC formulations of dapagliflozin and metformin XR tablets were bioequivalent in fed and fasted subjects. All treatments were well tolerated. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0004026 |
format | Online Article Text |
id | pubmed-10333646 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Korean Society for Clinical Pharmacology and Therapeutics |
record_format | MEDLINE/PubMed |
spelling | pubmed-103336462023-07-12 Fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects Lee, Hae Won Kang, Woo Youl Park, Ji Seo Lee, Jae Hwa Gwon, Mi-Ri Yang, Dong Heon Kim, Eun Hee Park, Soo-Jin Yoon, Young-Ran Seong, Sook Jin Transl Clin Pharmacol Original Article Two open-label, randomized, two-period crossover studies were conducted to investigate the pharmacokinetic (PK) properties, safety, and bioequivalence of the test formulation (KD4004), a new fixed-dose combination (FDC) formulation of dapagliflozin and metformin extended release (XR) tablets, relative to the reference formulation (10 mg dapagliflozin/1,000 mg metformin XR FDC tablet) in healthy subjects under fasting (Part A) and fed (Part B) conditions. After giving the dose, serial blood samples were collected for a period of 48 hours. Primary PK parameters (AUC(0-t) and C(max)) were used to assess bioequivalence between two dapagliflozin/metformin XR (10/1,000 mg) FDC formulations under fed and fasting conditions. Safety and tolerability were also evaluated. Part A and Part B were completed by 32 and 37 subjects, respectively. Bioequivalence of the two FDC formulations of dapagliflozin and metformin XR tablets was established in both the fasted and the fed conditions as the 90% confidence interval of the ratios of adjusted geometric means for AUC(0-t) and C(max) were contained within the predefined range of 0.800–1.250 bioequivalence criteria. Single-dose administration of dapagliflozin and metformin XR was safe and well tolerated as the two FDC formulations. In conclusion, both FDC formulations of dapagliflozin and metformin XR tablets were bioequivalent in fed and fasted subjects. All treatments were well tolerated. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0004026 Korean Society for Clinical Pharmacology and Therapeutics 2023-06 2023-06-26 /pmc/articles/PMC10333646/ /pubmed/37440782 http://dx.doi.org/10.12793/tcp.2023.31.e10 Text en Copyright © 2023 Translational and Clinical Pharmacology https://creativecommons.org/licenses/by-nc/4.0/It is identical to the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/). |
spellingShingle | Original Article Lee, Hae Won Kang, Woo Youl Park, Ji Seo Lee, Jae Hwa Gwon, Mi-Ri Yang, Dong Heon Kim, Eun Hee Park, Soo-Jin Yoon, Young-Ran Seong, Sook Jin Fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects |
title | Fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects |
title_full | Fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects |
title_fullStr | Fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects |
title_full_unstemmed | Fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects |
title_short | Fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects |
title_sort | fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10333646/ https://www.ncbi.nlm.nih.gov/pubmed/37440782 http://dx.doi.org/10.12793/tcp.2023.31.e10 |
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