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Comparative bioequivalence study of rifampicin and isoniazid combinations in healthy volunteers.
Int J Tuberc Lung Dis 1999; 3(7):627-31IJ

Abstract

OBJECTIVE

To assess the bioavailability of rifampicin (RMP) in three brands of combination formulations of anti-tuberculosis drugs.

DESIGN

A three-way double-blind, cross-over bioavailability study of RMP and isoniazid (INH), consisting of a comparison of a two-drug combination of tablets of RMP and INH each separately (reference brand R) and a tablet of RMP + INH (brand N), and a capsule of RMP + INH (brand L) was carried out in 12 healthy male volunteers. Coded plasma samples were analysed for levels of RMP as well as INH and acetylisoniazid (ACINH) by two high performance liquid chromatography (HPLC) methods.

RESULTS

The mean values of RMP in brand N (Cmax 6.49+/-0.52 microg/mL, Tmax 2.33+/-0.18 h, AUC(0-24h) 39.83+/-3.44 microg/mL.h) were comparable with those obtained with brand R (Cmax 5.22+/-0.59 microg/mL, Tmax 2.50+/-0.12 h, AUC(0-24h) 33.33+/-3.47 microg/mL.h). The mean values of RMP in brand L (Cmax 3.05+/-0.52 microg/ mL, Tmax 3.79+/-0.57 h and AUC(0-24h) 21.78+/-3.67 microg/ mL.h) were significantly different from those in brand R. Nevertheless, all of the pharmacokinetic parameters obtained for INH and ACINH in all three brands were comparable.

CONCLUSION

Using brand R as a comparison, brand N was bioequivalent and brand L was not bioequivalent.

Authors+Show Affiliations

Department of Clinical Pharmacology, LTM Medical College, Sion Hospital, Mumbai, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

10423226

Citation

Padgaonkar, K A., et al. "Comparative Bioequivalence Study of Rifampicin and Isoniazid Combinations in Healthy Volunteers." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 3, no. 7, 1999, pp. 627-31.
Padgaonkar KA, Revankar SN, Bhatt AD, et al. Comparative bioequivalence study of rifampicin and isoniazid combinations in healthy volunteers. Int J Tuberc Lung Dis. 1999;3(7):627-31.
Padgaonkar, K. A., Revankar, S. N., Bhatt, A. D., Vaz, J. A., Desai, N. D., D'Sa, S., ... Gandewar, K. (1999). Comparative bioequivalence study of rifampicin and isoniazid combinations in healthy volunteers. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 3(7), pp. 627-31.
Padgaonkar KA, et al. Comparative Bioequivalence Study of Rifampicin and Isoniazid Combinations in Healthy Volunteers. Int J Tuberc Lung Dis. 1999;3(7):627-31. PubMed PMID: 10423226.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative bioequivalence study of rifampicin and isoniazid combinations in healthy volunteers. AU - Padgaonkar,K A, AU - Revankar,S N, AU - Bhatt,A D, AU - Vaz,J A, AU - Desai,N D, AU - D'Sa,S, AU - Shah,V, AU - Gandewar,K, PY - 1999/7/28/pubmed PY - 1999/7/28/medline PY - 1999/7/28/entrez SP - 627 EP - 31 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 - 7 N2 - OBJECTIVE: To assess the bioavailability of rifampicin (RMP) in three brands of combination formulations of anti-tuberculosis drugs. DESIGN: A three-way double-blind, cross-over bioavailability study of RMP and isoniazid (INH), consisting of a comparison of a two-drug combination of tablets of RMP and INH each separately (reference brand R) and a tablet of RMP + INH (brand N), and a capsule of RMP + INH (brand L) was carried out in 12 healthy male volunteers. Coded plasma samples were analysed for levels of RMP as well as INH and acetylisoniazid (ACINH) by two high performance liquid chromatography (HPLC) methods. RESULTS: The mean values of RMP in brand N (Cmax 6.49+/-0.52 microg/mL, Tmax 2.33+/-0.18 h, AUC(0-24h) 39.83+/-3.44 microg/mL.h) were comparable with those obtained with brand R (Cmax 5.22+/-0.59 microg/mL, Tmax 2.50+/-0.12 h, AUC(0-24h) 33.33+/-3.47 microg/mL.h). The mean values of RMP in brand L (Cmax 3.05+/-0.52 microg/ mL, Tmax 3.79+/-0.57 h and AUC(0-24h) 21.78+/-3.67 microg/ mL.h) were significantly different from those in brand R. Nevertheless, all of the pharmacokinetic parameters obtained for INH and ACINH in all three brands were comparable. CONCLUSION: Using brand R as a comparison, brand N was bioequivalent and brand L was not bioequivalent. SN - 1027-3719 UR - https://www.unboundmedicine.com/medline/citation/10423226/Comparative_bioequivalence_study_of_rifampicin_and_isoniazid_combinations_in_healthy_volunteers_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1027-3719&volume=3&issue=7&spage=627&aulast=Padgaonkar DB - PRIME DP - Unbound Medicine ER -