Bioavailability of rifampicin in Indonesian subjects: a comparison of different local drug manufacturers

To examine the bioavailability of rifampicin formulations produced in Indonesia, we conducted a single-dose, double-blind, cross-over bioavailability study. Anti-tuberculosis drugs from three Indonesian manufacturers and one international manufacturer were compared in 12 healthy Indonesian subjects....

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Bibliographic Details
Published inThe international journal of tuberculosis and lung disease Vol. 8; no. 4; pp. 500 - 503
Main Authors VAN CREVEL, R, NELWAN, R. H, BORST, F, SAHIRATMADJA, E, COX, J, VAN DER MEIJ, W, DE GRAAFF, M, ALISJAHBANA, B, DE LANGE, W. C, BURGER, D
Format Journal Article
LanguageEnglish
Published Paris, France IUATLD 01.04.2004
Union internationale contre la tuberculose et les maladies respiratoires
Subjects
Adult
Antitubercular Agents - pharmacokinetics
Bacterial diseases
Biological and medical sciences
Biological Availability
Biological Bioavailability
Cross-Over Studies
Double-Blind Method
Formulation
Human bacterial diseases
Humans
Indonesia
Infectious diseases
Male
Medical sciences
Reference Values
rifampicin
Rifampin - pharmacokinetics
Tuberculosis and atypical mycobacterial infections
Tuberculosis Treatment
Indonesia
Human
Drug
tuberculosis treatment
Mycobacterial infection
Bioavailability
biological bioavailability
Infection
Antibiotic
Rifampicin
Treatment
Tuberculosis
Formulation
Bacteriosis
Manufacturer
Antibacterial agent
Comparative study
Indonesia
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Summary:To examine the bioavailability of rifampicin formulations produced in Indonesia, we conducted a single-dose, double-blind, cross-over bioavailability study. Anti-tuberculosis 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.
Bibliography:(R) Medicine - General
1027-3719(20040401)8:4L.500;1-
ObjectType-Article-2
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ObjectType-Feature-1
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ISSN:1027-3719
1815-7920