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Relative bioavailability of isoniazid in a fixed-dose combination product in healthy Mexican subjects.
Int J Tuberc Lung Dis 2014; 18(1):49-54IJ

Abstract

SETTING

Subtherapeutic plasma isoniazid (INH) concentrations and the development of bacterial resistance may be attributed to poor quality and reduced bioavailability of fixed-dose combination (FDC) formulations. The bioavailability of INH from a generic and that of a branded FDC formulation had not been compared in the Mexican population.

OBJECTIVE

To evaluate the bioequivalence of a generic three-drug FDC formulation (3FDC) in comparison with a 3FDC reference with doses of 300 mg INH in 20 healthy Mexican adults, and to generate data regarding the oral relative bioavailability of the drug in this population.

DESIGN

A single-dose, randomised-sequence, open-label, two-period crossover study.

RESULTS

Both formulations were well tolerated. The pharmacokinetic parameters of INH showed wide inter-individual variability. The average relative bioavailability calculated for maximum serum concentration area under the concentration-time curve (AUC), AUC(0-24h) and AUC(0-∞) of the test 3FDC formulation vs. the 3FDC reference were respectively 64.84% (90%CI 56.01-75.06), 59.05% (90%CI 50.27-69.36) and 57.26% (90%CI 46.93-69.84).

CONCLUSIONS

The 3FDC test and reference formulations were not bioequivalent because the 90%CI for the geometric mean ratios did not meet the regulatory requirements for bioequivalence (range 80-125%) based on the rate and extent of absorption.

Authors+Show Affiliations

Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí, San Luis Potosí, México.Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí, San Luis Potosí, México.Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí, San Luis Potosí, México.Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí, San Luis Potosí, México.Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí, San Luis Potosí, México.Servicio de Infectología, Hospital Central Dr. Ignacio Morones Prieto, Servicios Coordinados de Salud, San Luis Potosí, México.Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí, San Luis Potosí, México.

Pub Type(s)

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

Language

eng

PubMed ID

24365552

Citation

Milán-Segovia, R C., et al. "Relative Bioavailability of Isoniazid in a Fixed-dose Combination Product in Healthy Mexican Subjects." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 18, no. 1, 2014, pp. 49-54.
Milán-Segovia RC, Vigna-Pérez M, Romero-Méndez MC, et al. Relative bioavailability of isoniazid in a fixed-dose combination product in healthy Mexican subjects. Int J Tuberc Lung Dis. 2014;18(1):49-54.
Milán-Segovia, R. C., Vigna-Pérez, M., Romero-Méndez, M. C., Medellín-Garibay, S. E., Vargas-Morales, J. M., Magaña-Aquino, M., & Romano-Moreno, S. (2014). Relative bioavailability of isoniazid in a fixed-dose combination product in healthy Mexican subjects. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 18(1), pp. 49-54. doi:10.5588/ijtld.13.0266.
Milán-Segovia RC, et al. Relative Bioavailability of Isoniazid in a Fixed-dose Combination Product in Healthy Mexican Subjects. Int J Tuberc Lung Dis. 2014;18(1):49-54. PubMed PMID: 24365552.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Relative bioavailability of isoniazid in a fixed-dose combination product in healthy Mexican subjects. AU - Milán-Segovia,R C, AU - Vigna-Pérez,M, AU - Romero-Méndez,M C, AU - Medellín-Garibay,S E, AU - Vargas-Morales,J M, AU - Magaña-Aquino,M, AU - Romano-Moreno,S, PY - 2013/12/25/entrez PY - 2013/12/25/pubmed PY - 2014/8/29/medline SP - 49 EP - 54 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 - 1 N2 - SETTING: Subtherapeutic plasma isoniazid (INH) concentrations and the development of bacterial resistance may be attributed to poor quality and reduced bioavailability of fixed-dose combination (FDC) formulations. The bioavailability of INH from a generic and that of a branded FDC formulation had not been compared in the Mexican population. OBJECTIVE: To evaluate the bioequivalence of a generic three-drug FDC formulation (3FDC) in comparison with a 3FDC reference with doses of 300 mg INH in 20 healthy Mexican adults, and to generate data regarding the oral relative bioavailability of the drug in this population. DESIGN: A single-dose, randomised-sequence, open-label, two-period crossover study. RESULTS: Both formulations were well tolerated. The pharmacokinetic parameters of INH showed wide inter-individual variability. The average relative bioavailability calculated for maximum serum concentration area under the concentration-time curve (AUC), AUC(0-24h) and AUC(0-∞) of the test 3FDC formulation vs. the 3FDC reference were respectively 64.84% (90%CI 56.01-75.06), 59.05% (90%CI 50.27-69.36) and 57.26% (90%CI 46.93-69.84). CONCLUSIONS: The 3FDC test and reference formulations were not bioequivalent because the 90%CI for the geometric mean ratios did not meet the regulatory requirements for bioequivalence (range 80-125%) based on the rate and extent of absorption. SN - 1815-7920 UR - https://www.unboundmedicine.com/medline/citation/24365552/Relative_bioavailability_of_isoniazid_in_a_fixed_dose_combination_product_in_healthy_Mexican_subjects_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1027-3719&volume=18&issue=1&spage=49&aulast=Milán-Segovia DB - PRIME DP - Unbound Medicine ER -