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KMID : 1038020180260010016
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Translational and Clinical Pharmacology
2018 Volume.26 No. 1 p.16 ~ p.24
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Pharmacokinetics of fixed-dose combination of rosuvastatin 20 mg and ezetimibe 10 mg compared to concurrent administration of individual tablets in healthy Korean subjects
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Hwang In-Young
Park Sang-In
Lee Seung-Hwan
Lee Back-Hwan
Yu Kyung-Sang
Jeon Ji-Young
Kim Min-Gul
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Abstract
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This study aimed to compare the pharmacokinetics of fixed-dose combination (FDC) tablet of rosuvastatin 20 mg/ezetimibe 10 mg with that of concurrent administration of individual rosuvastatin 20 mg tablet and ezetimibe 10 mg tablet in healthy subjects. A randomized, open label, single-dose, two-way crossover study was conducted. Subjects randomly received test formulation (FDC tablet of rosuvastatin 20 mg/ezetimibe 10 mg) or reference formulation (co-administration of rosuvastatin 20 mg tablet and ezetimibe 10 mg tablet). After 2 weeks of washout, subjects received the other treatment. Blood samples were collected up to 72 hours post-dose in each period. Plasma concentrations of rosuvastatin, ezetimibe and total ezetimibe (ezetimibe + ezetimibe glucuronide) were analyzed by liquid chromatography-tandem mass spectrometry (LC/MS/MS). The geometric mean ratio (GMR) of Cmax and AUClast (90% confidence interval, CI) for rosuvastatin was 1.036 (0.979-1.096) and 1.024 (0.981-1.070), respectively. The corresponding values for ezetimibe were 0.963 (0.888-1.043) and 1.021 (0.969-1.074), respectively. The corresponding values for total ezetimibe were 0.886 (0.835-0.940) and 0.983 (0.946-1.022), respectively. FDC tablet containing rosuvastatin 20 mg and ezetimibe 10 mg is bioequivalent to the co-administration of commercially available individual tablets of rosuvastatin and ezetimibe as GMR with 90% CI of Cmax and AUClast of rosuvastatin, ezetimibe and total ezetimibe were contained within conventionally accepted bioequivalence criteria.
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KEYWORD
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Rosuvastatin, Ezetimibe, Fixed-dose combination, Pharmacokinetics, Bioequivalence
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