Tags

Type your tag names separated by a space and hit enter

Comparative bioavailability of rifampicin and isoniazid in fixed-dose combinations and single-drug formulations.
Int J Tuberc Lung Dis 2014; 18(12):1505-12IJ

Abstract

SETTING

The bioavailability of rifampicin (RMP) decreases by ∼30% on interaction with isoniazid (INH) in stomach acid conditions, which can result in the development of drug resistance and treatment failure.

OBJECTIVE

To compare the bioavailability in healthy volunteers of five anti-tuberculosis fixed-drug combinations (FDCs) used in China (formulations A-E) containing RMP and INH against single-drug formulations taken as reference.

DESIGN

Two- or three-period, two- or three-sequence crossover study of drugs.

RESULT

Only RMP formulation E passed the bioequivalence criteria, with 90% confidence intervals for the log-transformed ratios of AUC₀₋₂₄, AUC₀₋∞, and Cmax of respectively 89.9-103.7, 89.6-102.2 and 87.7-107.9. For INH, formulations A, B, C and D passed the bioequivalence test, but not product E, where the 90%CIs of the log-transformed ratios of AUC₀₋₂₄, AUC₀₋∞, and Cmax were respectively 85.2-100.7, 85.2-100.7 and 73.8-100.9.

CONCLUSION

According to the results of the bioequivalence analysis carried out in this study, RMP formulations A, B, C and D were not within the acceptable range and only formulation E passed the bioequivalence criteria of 80-125%. In comparison, four-test INH formulations (A, B, C and D) were bioequivalent to the corresponding single-drug formulation, while product E failed in the bioequivalence criteria.

Authors+Show Affiliations

Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Department of Pharmacology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, China.Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Department of Pharmacology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, China.Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Department of Pharmacology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, China.Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Department of Pharmacology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, China.Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Department of Pharmacology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, China.Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Department of Pharmacology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, China.National Center for Tuberculosis Control and Prevention, Chinese Centers for Disease Control and Prevention, Beijing, China.National Center for Tuberculosis Control and Prevention, Chinese Centers for Disease Control and Prevention, Beijing, China.National Center for Tuberculosis Control and Prevention, Chinese Centers for Disease Control and Prevention, Beijing, China.Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Department of Pharmacology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, China.Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Department of Pharmacology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, China.Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Department of Pharmacology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, China.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25517820

Citation

Hao, L-H, et al. "Comparative Bioavailability of Rifampicin and Isoniazid in Fixed-dose Combinations and Single-drug Formulations." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 18, no. 12, 2014, pp. 1505-12.
Hao LH, Guo SC, Liu CC, et al. Comparative bioavailability of rifampicin and isoniazid in fixed-dose combinations and single-drug formulations. Int J Tuberc Lung Dis. 2014;18(12):1505-12.
Hao, L. H., Guo, S. C., Liu, C. C., Zhu, H., Wang, B., Fu, L., ... Lu, Y. (2014). Comparative bioavailability of rifampicin and isoniazid in fixed-dose combinations and single-drug formulations. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 18(12), pp. 1505-12. doi:10.5588/ijtld.13.0647.
Hao LH, et al. Comparative Bioavailability of Rifampicin and Isoniazid in Fixed-dose Combinations and Single-drug Formulations. Int J Tuberc Lung Dis. 2014;18(12):1505-12. PubMed PMID: 25517820.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative bioavailability of rifampicin and isoniazid in fixed-dose combinations and single-drug formulations. AU - Hao,L-H, AU - Guo,S-C, AU - Liu,C-C, AU - Zhu,H, AU - Wang,B, AU - Fu,L, AU - Chen,M-T, AU - Zhou,L, AU - Chi,J-Y, AU - Yang,W, AU - Nie,W-J, AU - Lu,Y, PY - 2014/12/18/entrez PY - 2014/12/18/pubmed PY - 2015/8/19/medline SP - 1505 EP - 12 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 - 18 IS - 12 N2 - SETTING: The bioavailability of rifampicin (RMP) decreases by ∼30% on interaction with isoniazid (INH) in stomach acid conditions, which can result in the development of drug resistance and treatment failure. OBJECTIVE: To compare the bioavailability in healthy volunteers of five anti-tuberculosis fixed-drug combinations (FDCs) used in China (formulations A-E) containing RMP and INH against single-drug formulations taken as reference. DESIGN: Two- or three-period, two- or three-sequence crossover study of drugs. RESULT: Only RMP formulation E passed the bioequivalence criteria, with 90% confidence intervals for the log-transformed ratios of AUC₀₋₂₄, AUC₀₋∞, and Cmax of respectively 89.9-103.7, 89.6-102.2 and 87.7-107.9. For INH, formulations A, B, C and D passed the bioequivalence test, but not product E, where the 90%CIs of the log-transformed ratios of AUC₀₋₂₄, AUC₀₋∞, and Cmax were respectively 85.2-100.7, 85.2-100.7 and 73.8-100.9. CONCLUSION: According to the results of the bioequivalence analysis carried out in this study, RMP formulations A, B, C and D were not within the acceptable range and only formulation E passed the bioequivalence criteria of 80-125%. In comparison, four-test INH formulations (A, B, C and D) were bioequivalent to the corresponding single-drug formulation, while product E failed in the bioequivalence criteria. SN - 1815-7920 UR - https://www.unboundmedicine.com/medline/citation/25517820/Comparative_bioavailability_of_rifampicin_and_isoniazid_in_fixed_dose_combinations_and_single_drug_formulations_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1027-3719&volume=18&issue=12&spage=1505&aulast=Hao DB - PRIME DP - Unbound Medicine ER -