Evaluation of rifampicin bioequivalence in fixed-dose combinations using the WHO/IUATLD recommended protocol

For an accurate assessment of rifampicin bioequivalence from fixed-dose com binations (FDCs), and to reduce the time and cost constraints associated wi th bioequivalence studies, the World Health Organization and the Internatio nal Union Against Tuberculosis and Lung Disease have developed a simplified screening protocol. This study was undertaken with the objective of testin g the applicability of this protocol for all types of FDCs. Data were obtai ned for volunteers common to three studies, and pharmacokinetic parameters were evaluated by different statistical tests. From the results, it has bee n demonstrated that the simplified screening protocol is suitable for evalu ating the bioequivalence of rifampicin in all the types of FDCs available o n the market.