혈청 테스토스테론 농도 측정에 의한 로렐린 데포 주사제의 약효 비교 시험

Abstract

【The purpose of this study was to compare the efficacy of Lorelin Depot $Injection^{(R)}$ (Dongkook Pharm. Co., LTD) with Lucrin Depot $Injection^{(R)}$ (Abbott) by measuring serum testosterone level in rats. Leuprorelin (leuprolide acetate), which is an active compound for the two formulations, is an LHRH analogue that is used for the treatment of a wide range of sex hormone-related disorders including advanced prostatic cancer, endometriosis and precocious puberty. Lorelin Depot $Injection^{(R)}$ is a micro-encapsulated formulation to suppress testosterone level by releasing leuprorelin continuously for four weeks with a single subcutaneous injection. The comparison study of the efficacy was performed during four weeks, and serum testosterone levels were monitored in the two formulations. The mean serum testosterone levels from the formulations were decreased to that of the castrate range (50 ng/dL or less) after three days after the initial depot injection, and the concentration were remained throughout four weeks' period. There were no significant differences in the $AUC_{0-3day}$ of testosterone and testosterone levels at 3, 7, 14, 21 and 28 days between the two formulations. These results indicate that the two formulations, Lorelin Depot $Injection^{(R)}$ and Lucrin Depot $Injection^{(R)}$ , are bioequivalent in terms of the serum testosterone level in rats.】