The WHO Simplified Study Protocol in practice: investigation of combined formulations supplied by the WHO
OBJECTIVES: To evaluate the comparative bioavailability of antituberculosis drugs in FDC formulations and the same doses in separate formulations of antituberculosis drugs, using a simplified protocol developed by the World Health Organization (WHO).
METHODS: Twenty healthy volunteers were included in the study and evaluated for bioequivalence of rifampicin in a cross-over experimental design. After administration of drugs the plasma concentration of rifampicin and desacetyl-rifampicin was measured repeatedly up to 8 hours in both plasma and urine. Various pharmacokinetic parameters of rifampicin, such as Cmax, Tmax, elimination rate constant, area under the curve (AUC) up to 8 hours and absorption efficiency were calculated.
RESULTS: No significant differences were observed between the FDCs and separate formulations when Cmax, Tmax, AUC and absorption efficiencies were compared by parametric test and Hauschke's analysis.
CONCLUSION: The WHO simplified protocol is suitable for evaluating bioequivalence of antituberculosis drugs.
Document Type: Regular Paper
Affiliations: Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Punjab, India
Publication date: 1999-11-01
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