Bioavailability of rifampicin in Indonesian subjects: a comparison of different local drug manufacturers.
until further notice
SourceInternational Journal of Tuberculosis and Lung Disease, 8, 4, (2004), pp. 500-3
Article / Letter to editor
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International Journal of Tuberculosis and Lung Disease
SubjectEBP 3: Effective Primary Care and Public Health; UMCN 4.1: Microbial pathogenesis and host defense
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.
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