카두라 정(독사조신 2mg)에 대한 카르딜 정의 생물학적 동등성 = Bioequivalence of Cardil Tablet to Cardura Tablet(Doxazosin 2 mg)

다국어 초록 (Multilingual Abstract)

Doxazosin, a postsynaptic selective α1-adrenoceptor antagonist, is a potent antihypertensive agent which reduces peripheral resistance and blood pressure by vasodilatation of peripheral vessels. It is also used in the treatment of urinary obstruction by benign prostatic hypertrophy. The purpose of the present study was to evaluate the bioaquivalence of two doxazosin tablet. Cardura^(TM) (Pfizer Korea Ltd.) and Cardil^(TM) (Kyongdong Pharmaceutical Co., Ltd), according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers, 24.19±2.48 years in age and 62.41±6.66 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After were tablet containing 2 ㎎ of doxazosin was orally administered, blood was taken at predetermined time intervals and the concentrations of doxazosin in serum were determined with an HPLC method using spectrofluorometric detector. Pharmacokinetic parameters such as AUC_t, C_(max) and T_(max) were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC_t, C_(max) and T_(max) between two tablets were -1.54%, -1.51% and 3.42%, respectively, when calculated against the Cardura^(TM) tablet. The powers (1-β) for AUC_t, C_(max) and T_(max) were all more than 99.00%. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were all less than 20% (e.g., 12.73%, 12.84% and 13.01% for AUC_t, C_(max) and T_(max) respectively). The 90% confidence intervals were all within ±20% (e.g., -8.97∼5.90, -9.01∼6.00 and -4.16∼11.05 for AUC_t, C_(max) and T_(max) respectively). All of the above pare- meters met the criteria of KFDA for bioequivalence, indicating that Cardil^(TM) tablet is bioequivalent to Cardura^(TM) tablet.