Document Detail

Bioavailability of rifampicin in Indonesian subjects: a comparison of different local drug manufacturers.
MedLine Citation:
PMID:  15141745     Owner:  NLM     Status:  MEDLINE    
To examine the bioavailability of rifampicin formulations produced in Indonesia, we conducted a single-dose, double-blind, cross-over bioavailability study. Antituberculosis drugs from three Indonesian manufacturers and one international manufacturer were compared in 12 healthy Indonesian subjects. Out of three local manufacturers, two showed equal bioavailability compared to the reference standard, and one showed slightly lower bioavailability (ratio 0.86; 90% confidence interval 0.80-0.91) and substandard rifampicin content of drug preparations. Plasma rifampicin concentrations in this study were more than three-fold higher than concentrations recently found in tuberculosis patients in Indonesia, which suggests that unknown (disease-related) determinants may reduce the bioavailability of rifampicin formulations.
R van Crevel; R H Nelwan; F Borst; E Sahiratmadja; J Cox; W van der Meij; M de Graaff; B Alisjahbana; W C de Lange; D Burger
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Controlled Clinical Trial; Journal Article    
Journal Detail:
Title:  The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease     Volume:  8     ISSN:  1027-3719     ISO Abbreviation:  Int. J. Tuberc. Lung Dis.     Publication Date:  2004 Apr 
Date Detail:
Created Date:  2004-05-14     Completed Date:  2004-08-03     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9706389     Medline TA:  Int J Tuberc Lung Dis     Country:  France    
Other Details:
Languages:  eng     Pagination:  500-3     Citation Subset:  IM    
Department of Internal Medicine, University Medical Center Nijmegen, Nijmegen, The Netherlands.
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MeSH Terms
Antitubercular Agents / pharmacokinetics*
Biological Availability
Cross-Over Studies
Double-Blind Method
Reference Values
Rifampin / pharmacokinetics*
Reg. No./Substance:
0/Antitubercular Agents; 13292-46-1/Rifampin

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