Document Detail

Comparative bioequivalence study of rifampicin and isoniazid combinations in healthy volunteers.
MedLine Citation:
PMID:  10423226     Owner:  NLM     Status:  MEDLINE    
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.
K A Padgaonkar; S N Revankar; A D Bhatt; J A Vaz; N D Desai; S D'Sa; V Shah; K Gandewar
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease     Volume:  3     ISSN:  1027-3719     ISO Abbreviation:  Int. J. Tuberc. Lung Dis.     Publication Date:  1999 Jul 
Date Detail:
Created Date:  1999-09-22     Completed Date:  1999-09-22     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9706389     Medline TA:  Int J Tuberc Lung Dis     Country:  FRANCE    
Other Details:
Languages:  eng     Pagination:  627-31     Citation Subset:  IM    
Department of Clinical Pharmacology, LTM Medical College, Sion Hospital, Mumbai, India.
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MeSH Terms
Antibiotics, Antitubercular / administration & dosage,  blood,  pharmacokinetics*
Antitubercular Agents / administration & dosage,  blood,  pharmacokinetics*
Area Under Curve
Biological Availability
Chromatography, High Pressure Liquid
Cross-Over Studies
Double-Blind Method
Drug Administration Schedule
Drug Combinations
Drug Therapy, Combination
Isoniazid / administration & dosage,  blood,  pharmacokinetics*
Reference Values
Rifampin / administration & dosage,  blood,  pharmacokinetics*
Therapeutic Equivalency
Reg. No./Substance:
0/Antibiotics, Antitubercular; 0/Antitubercular Agents; 0/Drug Combinations; 13292-46-1/Rifampin; 54-85-3/Isoniazid

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