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Free Content Comparative bioequivalence study of rifampicin and isoniazid combinations in healthy volunteers

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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 μg/mL, Tmax 2.33 ± 0.18 h, AUC(0–24) 39.83 ± 3.44 μg/mL.h) were comparable with those obtained with brand R (Cmax 5.22 ± 0.59 μg/mL, Tmax 2.50 ± 0.12 h, AUC(0–24) 33.33 ± 3.47 μg/mL.h). The mean values of RMP in brand L (Cmax 3.05 ± 0.52 μg/mL, Tmax 3.79 ± 0.57 h and AUC(0–24) 21.78 ± 3.67 μg/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.
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Keywords: bioavailability; multidrug combinations; rifampicin

Document Type: Regular Paper

Affiliations: 1: Department of Clinical Pharmacology, LTM Medical College, Sion Hospital, Mumbai, India 2: Novartis India Limited, Medical Department, Khetan Bhavan, Churchgate, Mumbai, India

Publication date: July 1, 1999

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on lung health world-wide.

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