Tags

Type your tag names separated by a space and hit enter

Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination.
Int J Tuberc Lung Dis 2015; 19(3):333-8IJ

Abstract

BACKGROUND

RIN(®)-150 is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg) and isoniazid (INH, 75 mg) developed for the treatment of tuberculosis.

SETTING

This study was conducted at a single center: the Pfizer Clinical Research Unit in Singapore.

OBJECTIVE

To demonstrate bioequivalence of each drug component between RIN-150 and individual products in a loose combination.

DESIGN

This was a randomized, open-label, single-dose, two-way crossover study. Subjects received single doses of RIN-150 or two individual reference 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 (Cmax) and the area under plasma concentration-time curve (AUC).

RESULTS

Of 28 subjects enrolled, 26 completed the study. The adjusted geometric mean ratios of Cmax and AUClast between the FDC and single-drug references and 90% confidence intervals were respectively 91.63% (90%CI 83.13-101.01) and 95.45% (90%CI 92.07-98.94) for RMP, and 107.58% (90%CI 96.07-120.47) and 103.45% (90%CI 99.33-107.75) for INH. Both formulations were generally well tolerated in this study.

CONCLUSION

The RIN-150 FDC tablet formulation is bioequivalent to the two single-drug references for RMP and INH at equivalent doses.

Authors+Show Affiliations

Pfizer Inc., Groton, Connecticut, USA.Pfizer Inc., Groton, Connecticut, USA.Pfizer Inc., Groton, Connecticut, USA.Pfizer Inc., New York City, New York, USA.Pfizer Inc., New York City, New York, USA.

Pub Type(s)

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

Language

eng

PubMed ID

25686143

Citation

Wang, H F., et al. "Bioequivalence of Fixed-dose Combination RIN®-150 to Each Reference Drug in Loose Combination." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 19, no. 3, 2015, pp. 333-8.
Wang HF, Wang R, O'Gorman M, et al. Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination. Int J Tuberc Lung Dis. 2015;19(3):333-8.
Wang, H. F., Wang, R., O'Gorman, M., Crownover, P., & Damle, B. (2015). Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 19(3), pp. 333-8. doi:10.5588/ijtld.14.0447.
Wang HF, et al. Bioequivalence of Fixed-dose Combination RIN®-150 to Each Reference Drug in Loose Combination. Int J Tuberc Lung Dis. 2015;19(3):333-8. PubMed PMID: 25686143.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination. AU - Wang,H F, AU - Wang,R, AU - O'Gorman,M, AU - Crownover,P, AU - Damle,B, PY - 2015/2/17/entrez PY - 2015/2/17/pubmed PY - 2015/12/25/medline SP - 333 EP - 8 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 - 19 IS - 3 N2 - BACKGROUND: RIN(®)-150 is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg) and isoniazid (INH, 75 mg) developed for the treatment of tuberculosis. SETTING: This study was conducted at a single center: the Pfizer Clinical Research Unit in Singapore. OBJECTIVE: To demonstrate bioequivalence of each drug component between RIN-150 and individual products in a loose combination. DESIGN: This was a randomized, open-label, single-dose, two-way crossover study. Subjects received single doses of RIN-150 or two individual reference 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 (Cmax) and the area under plasma concentration-time curve (AUC). RESULTS: Of 28 subjects enrolled, 26 completed the study. The adjusted geometric mean ratios of Cmax and AUClast between the FDC and single-drug references and 90% confidence intervals were respectively 91.63% (90%CI 83.13-101.01) and 95.45% (90%CI 92.07-98.94) for RMP, and 107.58% (90%CI 96.07-120.47) and 103.45% (90%CI 99.33-107.75) for INH. Both formulations were generally well tolerated in this study. CONCLUSION: The RIN-150 FDC tablet formulation is bioequivalent to the two single-drug references for RMP and INH at equivalent doses. SN - 1815-7920 UR - https://www.unboundmedicine.com/medline/citation/25686143/Bioequivalence_of_fixed_dose_combination_RIN®_150_to_each_reference_drug_in_loose_combination_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1027-3719&volume=19&issue=3&spage=333&aulast=Wang DB - PRIME DP - Unbound Medicine ER -