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Free Content Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination

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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.
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Keywords: anti-tuberculosis drugs; isoniazid; rifampicin

Document Type: Research Article

Affiliations: 1: *Pfizer Inc., Groton, Connecticut 2: Pfizer Inc., New York City, New York, USA

Publication date: 01 March 2015

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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