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Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination
H F Wang1, R Wang1, M O'Gorman1
1Pfizer Inc., Groton, Connecticut, USA.
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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