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Relative Bioavailability of Rifampicin in Four Chinese Fixed-dose Combinations Compared with Rifampicin in Free Combinations

Background:Decreases in the bioavailability of rifampicin (RFP) can lead to the development of drug resistance and treatment failure.Therefore,we investigated the relative bioavailability of RFP from one four-drug fixed-dose combination (FDC; formulation A) and three two-drug FDCs (formulations B,C,... Full description

Journal Title: Chinese medical journal 2015, Vol.128 (4), p.433-437
Main Author: Hui Zhu
Other Authors: Shao-Chen Guo , Lan-Hu Hao , Cheng-Cheng Liu , Bin Wang , Lei Fu , Ming-Ting Chen
Format: Electronic Article Electronic Article
Language: English
Publisher: Department of Pharmacology, Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumour Research Institute, Beijing 101149, China%Department of Patient Care Services, National Center for Tuberculosis Control and Prevention, Chinese Centers for Disease Control and Prevention, Beijing 102206, China
ID: ISSN: 0366-6999
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recordid: cdi_wanfang_journals_zhcmj201504002
title: Relative Bioavailability of Rifampicin in Four Chinese Fixed-dose Combinations Compared with Rifampicin in Free Combinations
format: Article
creator:
  • Hui Zhu
  • Shao-Chen Guo
  • Lan-Hu Hao
  • Cheng-Cheng Liu
  • Bin Wang
  • Lei Fu
  • Ming-Ting Chen
ispartof: Chinese medical journal, 2015, Vol.128 (4), p.433-437
description: Background:Decreases in the bioavailability of rifampicin (RFP) can lead to the development of drug resistance and treatment failure.Therefore,we investigated the relative bioavailability of RFP from one four-drug fixed-dose combination (FDC; formulation A) and three two-drug FDCs (formulations B,C,and D) used in China,compared with RFP in free combinations of these drugs (reference),in healthy volunteers.Methods:Eighteen and twenty healthy Chinese male volunteers participated in two open-label,randomized two-period crossover (formulations A and C) or one three-period crossover (formulations B and D) study,respectively.The washout period between treatments was 7 days.Bioequivalence was assessed based on 90% confidence intervals,according to two one-sided t-tests.All analyses were done with DAS 3.1.5 (Mathematical Pharmacology Professional Committee of China,Shanghai,China).Results:Mean pharmacokinetic parameter values of RFP obtained for formulations A,B,C,and D products were 11.42 ± 3.41 μg/ml,7.86 ± 5.78 μg
language: eng
source:
identifier: ISSN: 0366-6999
fulltext: no_fulltext
issn:
  • 0366-6999
  • 2542-5641
url: Link


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titleRelative Bioavailability of Rifampicin in Four Chinese Fixed-dose Combinations Compared with Rifampicin in Free Combinations
creatorHui Zhu ; Shao-Chen Guo ; Lan-Hu Hao ; Cheng-Cheng Liu ; Bin Wang ; Lei Fu ; Ming-Ting Chen
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descriptionBackground:Decreases in the bioavailability of rifampicin (RFP) can lead to the development of drug resistance and treatment failure.Therefore,we investigated the relative bioavailability of RFP from one four-drug fixed-dose combination (FDC; formulation A) and three two-drug FDCs (formulations B,C,and D) used in China,compared with RFP in free combinations of these drugs (reference),in healthy volunteers.Methods:Eighteen and twenty healthy Chinese male volunteers participated in two open-label,randomized two-period crossover (formulations A and C) or one three-period crossover (formulations B and D) study,respectively.The washout period between treatments was 7 days.Bioequivalence was assessed based on 90% confidence intervals,according to two one-sided t-tests.All analyses were done with DAS 3.1.5 (Mathematical Pharmacology Professional Committee of China,Shanghai,China).Results:Mean pharmacokinetic parameter values of RFP obtained for formulations A,B,C,and D products were 11.42 ± 3.41 μg/ml,7.86 ± 5.78 μg
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descriptionBackground:Decreases in the bioavailability of rifampicin (RFP) can lead to the development of drug resistance and treatment failure.Therefore,we investigated the relative bioavailability of RFP from one four-drug fixed-dose combination (FDC; formulation A) and three two-drug FDCs (formulations B,C,and D) used in China,compared with RFP in free combinations of these drugs (reference),in healthy volunteers.Methods:Eighteen and twenty healthy Chinese male volunteers participated in two open-label,randomized two-period crossover (formulations A and C) or one three-period crossover (formulations B and D) study,respectively.The washout period between treatments was 7 days.Bioequivalence was assessed based on 90% confidence intervals,according to two one-sided t-tests.All analyses were done with DAS 3.1.5 (Mathematical Pharmacology Professional Committee of China,Shanghai,China).Results:Mean pharmacokinetic parameter values of RFP obtained for formulations A,B,C,and D products were 11.42 ± 3.41 μg/ml,7.86 ± 5.78 μg
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abstractBackground:Decreases in the bioavailability of rifampicin (RFP) can lead to the development of drug resistance and treatment failure.Therefore,we investigated the relative bioavailability of RFP from one four-drug fixed-dose combination (FDC; formulation A) and three two-drug FDCs (formulations B,C,and D) used in China,compared with RFP in free combinations of these drugs (reference),in healthy volunteers.Methods:Eighteen and twenty healthy Chinese male volunteers participated in two open-label,randomized two-period crossover (formulations A and C) or one three-period crossover (formulations B and D) study,respectively.The washout period between treatments was 7 days.Bioequivalence was assessed based on 90% confidence intervals,according to two one-sided t-tests.All analyses were done with DAS 3.1.5 (Mathematical Pharmacology Professional Committee of China,Shanghai,China).Results:Mean pharmacokinetic parameter values of RFP obtained for formulations A,B,C,and D products were 11.42 ± 3.41 μg/ml,7.86 ± 5.78 μg
pubDepartment of Pharmacology, Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumour Research Institute, Beijing 101149, China%Department of Patient Care Services, National Center for Tuberculosis Control and Prevention, Chinese Centers for Disease Control and Prevention, Beijing 102206, China
doi10.4103/0366-6999.151061