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The WHO simplified study protocol in practice: investigation of combined formulations supplied by the WHO.
Int J Tuberc Lung Dis. 1999 Nov; 3(11 Suppl 3):S336-42; discussion S351-2.IJ

Abstract

SETTING

The benefits of fixed-dose combination (FDC) formulations of rifampicin, isoniazid and pyrazinamide over individual formulations are well recognised.

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.

Authors+Show Affiliations

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Punjab, India. panchagnula@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

10593714

Citation

Panchagnula, R, et al. "The WHO Simplified Study Protocol in Practice: Investigation of Combined Formulations Supplied By the WHO." 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. S336-42; discussion S351-2.
Panchagnula R, Kaur KJ, Singh I, et al. The WHO simplified study protocol in practice: investigation of combined formulations supplied by the WHO. Int J Tuberc Lung Dis. 1999;3(11 Suppl 3):S336-42; discussion S351-2.
Panchagnula, R., Kaur, K. J., Singh, I., & Kaul, C. L. (1999). The WHO simplified study protocol in practice: investigation of combined formulations supplied by the WHO. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 3(11 Suppl 3), S336-42; discussion S351-2.
Panchagnula R, et al. The WHO Simplified Study Protocol in Practice: Investigation of Combined Formulations Supplied By the WHO. Int J Tuberc Lung Dis. 1999;3(11 Suppl 3):S336-42; discussion S351-2. PubMed PMID: 10593714.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The WHO simplified study protocol in practice: investigation of combined formulations supplied by the WHO. AU - Panchagnula,R, AU - Kaur,K J, AU - Singh,I, AU - Kaul,C L, PY - 1999/12/11/pubmed PY - 1999/12/11/medline PY - 1999/12/11/entrez SP - S336-42; discussion S351-2 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: The benefits of fixed-dose combination (FDC) formulations of rifampicin, isoniazid and pyrazinamide over individual formulations are well recognised. 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. SN - 1027-3719 UR - https://www.unboundmedicine.com/medline/citation/10593714/The_WHO_simplified_study_protocol_in_practice:_investigation_of_combined_formulations_supplied_by_the_WHO_ DB - PRIME DP - Unbound Medicine ER -