레니프릴정(에날라프릴 10 mg)에 대한 에날라프릴정의 생물학적 동등성 평가
Bioequivalence Study of Enalapril Tablet to Lenipril® Tablet
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초록
The study was designed to compare the rate and extent of absorption of two enalapril tablets (10 mg), which has been widely used for the treatment of hypertension. This bioequivalence study was conducted using a standard preparation as reference and a generic as test in 24 male healthy volunteers. After an overnight fast, a single dose of the test or reference drugs were given with a washout period of 7 days. Heparinized blood samples were serially collected up to 10 hr. Plasma enalapril concentrations were quantified using a validated LC-MS/MS method. The data obtained for each subject was evaluated for Cmax and AUC10hr with respect to 90% confidence interval for log-transformed data. The 90% confidence intervals were log(0.9384)~log(1.1160) for AUC10hr and log(0.9482)~log(1.1474) for Cmax. Thus, we concluded that the test and reference formulation are bioequivalent in terms of rate and extent of absorption.
Abstract
The study was designed to compare the rate and extent of absorption of two enalapril tablets (10 mg), which has been widely used for the treatment of hypertension. This bioequivalence study was conducted using a standard preparation as reference and a generic as test in 24 male healthy volunteers. After an overnight fast, a single dose of the test or reference drugs were given with a washout period of 7 days. Heparinized blood samples were serially collected up to 10 hr. Plasma enalapril concentrations were quantified using a validated LC-MS/MS method. The data obtained for each subject was evaluated for Cmax and AUC10hr with respect to 90% confidence interval for log-transformed data. The 90% confidence intervals were log(0.9384)~log(1.1160) for AUC10hr and log(0.9482)~log(1.1474) for Cmax. Thus, we concluded that the test and reference formulation are bioequivalent in terms of rate and extent of absorption.
참고문헌 (9)
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