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Bioequivalence of rifampicin when administered as a fixed-dose combined formulation of four drugs versus separate formulations.
Methods Find Exp Clin Pharmacol. 2000 Nov; 22(9):689-94.MF

Abstract

A bioequivalence study of the antitubercular drug rifampicin in a four-drug combination (rifampicin, isoniazid, pyrazinamide and ethambutol) and separate formulations of the drugs at the same dose levels was carried out in a group of 22 healthy male volunteers. The investigation was designed as an open crossover study. The drugs were administered once in individual formulations and once in a fixed-dose combination. The WHO-approved protocol was followed according to which six blood samples were collected over a period of 8 h for each volunteer and each experimental session. Pooled urine samples were also collected during the study. Rifampicin and desacetyl rifampicin concentrations in both plasma and urine samples were assessed. Various pharmacokinetic parameters such as AUC0-8 h, Cmax and Tmax were calculated for both rifampicin and desacetyl rifampicin. The results indicated that combined (the four-drug combination) and separate formulations are bioequivalent for rifampicin.

Authors+Show Affiliations

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Punjab, India. panchagnula@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

11294011

Citation

Panchagnula, R, et al. "Bioequivalence of Rifampicin when Administered as a Fixed-dose Combined Formulation of Four Drugs Versus Separate Formulations." Methods and Findings in Experimental and Clinical Pharmacology, vol. 22, no. 9, 2000, pp. 689-94.
Panchagnula R, Kaur KJ, Singh I, et al. Bioequivalence of rifampicin when administered as a fixed-dose combined formulation of four drugs versus separate formulations. Methods Find Exp Clin Pharmacol. 2000;22(9):689-94.
Panchagnula, R., Kaur, K. J., Singh, I., & Kaul, C. L. (2000). Bioequivalence of rifampicin when administered as a fixed-dose combined formulation of four drugs versus separate formulations. Methods and Findings in Experimental and Clinical Pharmacology, 22(9), 689-94.
Panchagnula R, et al. Bioequivalence of Rifampicin when Administered as a Fixed-dose Combined Formulation of Four Drugs Versus Separate Formulations. Methods Find Exp Clin Pharmacol. 2000;22(9):689-94. PubMed PMID: 11294011.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bioequivalence of rifampicin when administered as a fixed-dose combined formulation of four drugs versus separate formulations. AU - Panchagnula,R, AU - Kaur,K J, AU - Singh,I, AU - Kaul,C L, PY - 2001/4/11/pubmed PY - 2001/7/20/medline PY - 2001/4/11/entrez SP - 689 EP - 94 JF - Methods and findings in experimental and clinical pharmacology JO - Methods Find Exp Clin Pharmacol VL - 22 IS - 9 N2 - A bioequivalence study of the antitubercular drug rifampicin in a four-drug combination (rifampicin, isoniazid, pyrazinamide and ethambutol) and separate formulations of the drugs at the same dose levels was carried out in a group of 22 healthy male volunteers. The investigation was designed as an open crossover study. The drugs were administered once in individual formulations and once in a fixed-dose combination. The WHO-approved protocol was followed according to which six blood samples were collected over a period of 8 h for each volunteer and each experimental session. Pooled urine samples were also collected during the study. Rifampicin and desacetyl rifampicin concentrations in both plasma and urine samples were assessed. Various pharmacokinetic parameters such as AUC0-8 h, Cmax and Tmax were calculated for both rifampicin and desacetyl rifampicin. The results indicated that combined (the four-drug combination) and separate formulations are bioequivalent for rifampicin. SN - 0379-0355 UR - https://www.unboundmedicine.com/medline/citation/11294011/Bioequivalence_of_rifampicin_when_administered_as_a_fixed_dose_combined_formulation_of_four_drugs_versus_separate_formulations_ L2 - http://journals.prous.com/journals/servlet/xmlxsl/pk_journals.xml_summaryn_pr?p_JournalId=6&p_RefId=802285 DB - PRIME DP - Unbound Medicine ER -