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. 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.
van Crevel
R
R
Department of Internal Medicine, University Medical Center Nijmegen, Nijmegen, The Netherlands. r.vancrevel@aig.umcn.nl
Nelwan
R H
RH
Borst
F
F
Sahiratmadja
E
E
Cox
J
J
van der Meij
W
W
de Graaff
M
M
Alisjahbana
B
B
de Lange
W C
WC
Burger
D
D
D000328:Adult; D000995:Antitubercular Agents / Q000493:pharmacokinetics*; D001682:Biological Availability; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006801:Humans; D007214:Indonesia; D008297:Male; D012016:Reference Values; D012293:Rifampin / Q000493:pharmacokinetics*
D000995:Antitubercular Agents; D012293:Rifampin