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Recent bioequivalence studies on fixed-dose combination anti-tuberculosis drug formulations available on the global market.
Int J Tuberc Lung Dis. 1999 Nov; 3(11 Suppl 3):S309-16; discussion S317-21.IJ

Abstract

SETTING

Concern has been expressed about the bioavailability of rifampicin in some fixed-dose combination (FDC) anti-tuberculosis formulations.

OBJECTIVE

To evaluate the relative bioavailability of rifampicin in various FDC formulations currently in use in tuberculosis control programmes in the global market.

DESIGN

A two-period randomised crossover bioequivalence study in healthy male volunteers, with a 1 week washout period between treatments. Plasma rifampicin concentrations were measured at 0, 1, 2, 4, 6, 8 and 12 hours after each drug administration.

RESULTS

The AUC0-8, AUC0-12 and Cmax for rifampicin in seven of 10 FDC formulations was not found to be bioequivalent to the reference administered as loose (separate) formulations. This was confirmed using parametric and non-parametric statistical methods.

CONCLUSIONS

The poor relative bioavailability of rifampicin from some FDCs has been documented. The implications for tuberculosis programmes are extremely serious and warrant urgent attention.

Authors+Show Affiliations

Department of Pharmacology, University of Durban Westville, South Africa. cpillai@pixie.udw.ac.zaNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

10593710

Citation

Pillai, G, et al. "Recent Bioequivalence Studies On Fixed-dose Combination Anti-tuberculosis Drug Formulations Available On the Global Market." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 3, no. 11 Suppl 3, 1999, pp. S309-16; discussion S317-21.
Pillai G, Fourie PB, Padayatchi N, et al. Recent bioequivalence studies on fixed-dose combination anti-tuberculosis drug formulations available on the global market. Int J Tuberc Lung Dis. 1999;3(11 Suppl 3):S309-16; discussion S317-21.
Pillai, G., Fourie, P. B., Padayatchi, N., Onyebujoh, P. C., McIlleron, H., Smith, P. J., & Gabriels, G. (1999). Recent bioequivalence studies on fixed-dose combination anti-tuberculosis drug formulations available on the global market. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 3(11 Suppl 3), S309-16; discussion S317-21.
Pillai G, et al. Recent Bioequivalence Studies On Fixed-dose Combination Anti-tuberculosis Drug Formulations Available On the Global Market. Int J Tuberc Lung Dis. 1999;3(11 Suppl 3):S309-16; discussion S317-21. PubMed PMID: 10593710.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Recent bioequivalence studies on fixed-dose combination anti-tuberculosis drug formulations available on the global market. AU - Pillai,G, AU - Fourie,P B, AU - Padayatchi,N, AU - Onyebujoh,P C, AU - McIlleron,H, AU - Smith,P J, AU - Gabriels,G, PY - 1999/12/11/pubmed PY - 1999/12/11/medline PY - 1999/12/11/entrez SP - S309-16; discussion S317-21 JF - The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease JO - Int. J. Tuberc. Lung Dis. VL - 3 IS - 11 Suppl 3 N2 - SETTING: Concern has been expressed about the bioavailability of rifampicin in some fixed-dose combination (FDC) anti-tuberculosis formulations. OBJECTIVE: To evaluate the relative bioavailability of rifampicin in various FDC formulations currently in use in tuberculosis control programmes in the global market. DESIGN: A two-period randomised crossover bioequivalence study in healthy male volunteers, with a 1 week washout period between treatments. Plasma rifampicin concentrations were measured at 0, 1, 2, 4, 6, 8 and 12 hours after each drug administration. RESULTS: The AUC0-8, AUC0-12 and Cmax for rifampicin in seven of 10 FDC formulations was not found to be bioequivalent to the reference administered as loose (separate) formulations. This was confirmed using parametric and non-parametric statistical methods. CONCLUSIONS: The poor relative bioavailability of rifampicin from some FDCs has been documented. The implications for tuberculosis programmes are extremely serious and warrant urgent attention. SN - 1027-3719 UR - https://www.unboundmedicine.com/medline/citation/10593710/Recent_bioequivalence_studies_on_fixed_dose_combination_anti_tuberculosis_drug_formulations_available_on_the_global_market_ L2 - http://www.diseaseinfosearch.org/result/7252 DB - PRIME DP - Unbound Medicine ER -