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Bioequivalence study of rifampicin in fixed-dose combination of rifampicin and isoniazid vs. separate formulations.
Methods Find Exp Clin Pharmacol. 1999 Nov; 21(9):625-8.MF

Abstract

The benefits of fixed-dose combinations of antituberculosis agents are well recognized by the World Health Organization (WHO) and International Union Against Tuberculosis and Lung Disease (IUATLD) and preferred over separate formulations. Therefore, a comparative bioequivalence study of rifampicin and isoniazid together in a fixed-dose combination and separately (at the same dose levels) was performed on a group of 12 healthy subjects. The study was designed as a single-blind, crossover experiment. Nine blood samples were collected from each subject over a period of 24 h. The plasma concentrations of rifampicin were assessed by a method developed in this laboratory. Various pharmacokinetic parameters of rifampicin such as AUC, Cmax, Tmax and t1/2 were also calculated. The study demonstrates that a fixed-dose combination (test formulation) and separate formulations (standard formulations) are bioequivalent for rifampicin.

Authors+Show Affiliations

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Punjab, India. niper@chd.nic.inNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

10669909

Citation

Panchagnula, R, et al. "Bioequivalence Study of Rifampicin in Fixed-dose Combination of Rifampicin and Isoniazid Vs. Separate Formulations." Methods and Findings in Experimental and Clinical Pharmacology, vol. 21, no. 9, 1999, pp. 625-8.
Panchagnula R, Singh I, Kaur KJ, et al. Bioequivalence study of rifampicin in fixed-dose combination of rifampicin and isoniazid vs. separate formulations. Methods Find Exp Clin Pharmacol. 1999;21(9):625-8.
Panchagnula, R., Singh, I., Kaur, K. J., & Kaul, C. L. (1999). Bioequivalence study of rifampicin in fixed-dose combination of rifampicin and isoniazid vs. separate formulations. Methods and Findings in Experimental and Clinical Pharmacology, 21(9), 625-8.
Panchagnula R, et al. Bioequivalence Study of Rifampicin in Fixed-dose Combination of Rifampicin and Isoniazid Vs. Separate Formulations. Methods Find Exp Clin Pharmacol. 1999;21(9):625-8. PubMed PMID: 10669909.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bioequivalence study of rifampicin in fixed-dose combination of rifampicin and isoniazid vs. separate formulations. AU - Panchagnula,R, AU - Singh,I, AU - Kaur,K J, AU - Kaul,C L, PY - 2000/2/12/pubmed PY - 2000/3/4/medline PY - 2000/2/12/entrez SP - 625 EP - 8 JF - Methods and findings in experimental and clinical pharmacology JO - Methods Find Exp Clin Pharmacol VL - 21 IS - 9 N2 - The benefits of fixed-dose combinations of antituberculosis agents are well recognized by the World Health Organization (WHO) and International Union Against Tuberculosis and Lung Disease (IUATLD) and preferred over separate formulations. Therefore, a comparative bioequivalence study of rifampicin and isoniazid together in a fixed-dose combination and separately (at the same dose levels) was performed on a group of 12 healthy subjects. The study was designed as a single-blind, crossover experiment. Nine blood samples were collected from each subject over a period of 24 h. The plasma concentrations of rifampicin were assessed by a method developed in this laboratory. Various pharmacokinetic parameters of rifampicin such as AUC, Cmax, Tmax and t1/2 were also calculated. The study demonstrates that a fixed-dose combination (test formulation) and separate formulations (standard formulations) are bioequivalent for rifampicin. SN - 0379-0355 UR - https://www.unboundmedicine.com/medline/citation/10669909/Bioequivalence_study_of_rifampicin_in_fixed_dose_combination_of_rifampicin_and_isoniazid_vs__separate_formulations_ L2 - http://journals.prous.com/journals/servlet/xmlxsl/pk_journals.xml_summaryn_pr?p_JournalId=6&p_RefId=795629 DB - PRIME DP - Unbound Medicine ER -