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Bioequivalence of fixed-dose combination Myrin®-P Forte and reference drugs in loose combination.
Int J Tuberc Lung Dis 2013; 17(12):1596-601IJ

Abstract

BACKGROUND

Myrin®-P Forte is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg), isoniazid (INH, 75 mg), ethambutol (EMB) hydrochloride (275 mg) and pyrazinamide (PZA, 400 mg) developed for the treatment of tuberculosis (TB).

SETTING

This study was conducted at a single centre--the Pfizer Clinical Research Unit in Singapore.

OBJECTIVE

To demonstrate the bioequivalence of each drug component of the Myrin-P Forte FDC and the individual product in loose combination.

DESIGN

In a randomized, open-label, single-dose, two-way, crossover study, subjects received single doses of Myrin-P Forte or four individual products under fasting conditions in a crossover fashion with at least 7 days washout between doses. The primary measures for comparison were peak plasma concentration (C(max)) and the area under plasma concentration-time curve (AUC).

RESULTS

Of 36 subjects enrolled, 35 completed the study. The adjusted geometric mean ratios and 90% confidence intervals for C(max) and AUC values were completely contained within bioequivalence limits (80%, 125%) for all four drugs in both formulations. Both treatments were generally well tolerated in the study.

CONCLUSION

The Myrin-P Forte FDC tablet formulation is bioequivalent to the four single-drug references for RMP, INH, EMB hydrochloride and PZA at equivalent doses.

Authors+Show Affiliations

Pfizer Inc, Groton, Connecticut, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24200275

Citation

Wang, H F., et al. "Bioequivalence of Fixed-dose Combination Myrin®-P Forte and Reference Drugs in Loose Combination." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 17, no. 12, 2013, pp. 1596-601.
Wang HF, Wang R, O'Gorman M, et al. Bioequivalence of fixed-dose combination Myrin®-P Forte and reference drugs in loose combination. Int J Tuberc Lung Dis. 2013;17(12):1596-601.
Wang, H. F., Wang, R., O'Gorman, M., Crownover, P., Naqvi, A., & Jafri, I. (2013). Bioequivalence of fixed-dose combination Myrin®-P Forte and reference drugs in loose combination. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 17(12), pp. 1596-601. doi:10.5588/ijtld.13.0190.
Wang HF, et al. Bioequivalence of Fixed-dose Combination Myrin®-P Forte and Reference Drugs in Loose Combination. Int J Tuberc Lung Dis. 2013;17(12):1596-601. PubMed PMID: 24200275.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bioequivalence of fixed-dose combination Myrin®-P Forte and reference drugs in loose combination. AU - Wang,H F, AU - Wang,R, AU - O'Gorman,M, AU - Crownover,P, AU - Naqvi,A, AU - Jafri,I, PY - 2013/11/9/entrez PY - 2013/11/10/pubmed PY - 2014/6/26/medline SP - 1596 EP - 601 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 - 17 IS - 12 N2 - BACKGROUND: Myrin®-P Forte is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg), isoniazid (INH, 75 mg), ethambutol (EMB) hydrochloride (275 mg) and pyrazinamide (PZA, 400 mg) developed for the treatment of tuberculosis (TB). SETTING: This study was conducted at a single centre--the Pfizer Clinical Research Unit in Singapore. OBJECTIVE: To demonstrate the bioequivalence of each drug component of the Myrin-P Forte FDC and the individual product in loose combination. DESIGN: In a randomized, open-label, single-dose, two-way, crossover study, subjects received single doses of Myrin-P Forte or four individual products under fasting conditions in a crossover fashion with at least 7 days washout between doses. The primary measures for comparison were peak plasma concentration (C(max)) and the area under plasma concentration-time curve (AUC). RESULTS: Of 36 subjects enrolled, 35 completed the study. The adjusted geometric mean ratios and 90% confidence intervals for C(max) and AUC values were completely contained within bioequivalence limits (80%, 125%) for all four drugs in both formulations. Both treatments were generally well tolerated in the study. CONCLUSION: The Myrin-P Forte FDC tablet formulation is bioequivalent to the four single-drug references for RMP, INH, EMB hydrochloride and PZA at equivalent doses. SN - 1815-7920 UR - https://www.unboundmedicine.com/medline/citation/24200275/Bioequivalence_of_fixed_dose_combination_Myrin®_P_Forte_and_reference_drugs_in_loose_combination_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1027-3719&volume=17&issue=12&spage=1596&aulast=Wang DB - PRIME DP - Unbound Medicine ER -