Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination
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.
Document Type: Research Article
Publication date: 2015-03-01
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