[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation, meloxicam nanocrystal injection (1 ml: 30 mg), and the reference preparation, Anjeso® (1 ml: 30 mg), in healthy adult subjects under fasting conditions.
主要试验目的:研究空腹状态下单次注射受试制剂美洛昔康纳米晶注射液(规格:1 ml:30 mg,江苏慧聚药业股份有限公司持有)与参比制剂美洛昔康纳米晶注射液(Anjeso®,规格:1 ml:30 mg;Baudax Bio,Inc.持证)在健康受试者体内的药代动力学特征,评价空腹状态静脉推注两种制剂的生物等效性。
次要试验目的:研究受试制剂美洛昔康纳米晶注射液(规格:1 ml:30mg)和参比制剂美洛昔康纳米晶注射液(Anjeso®,规格:1 ml:30 mg)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic characteristics of a single injection of the test preparation meloxicam nanocrystal injection (specification: 1 ml: 30 mg, held by Jiangsu Huiju Pharmaceutical Co., Ltd.) and the reference preparation meloxicam nanocrystal injection (Anjeso®, specification: 1 ml: 30 mg; licensed by Baudax Bio, Inc.) in healthy subjects under fasting conditions, and to evaluate the bioequivalence of the two preparations by intravenous injection under fasting conditions.
Secondary purpose of the study is to study the safety of the test preparation meloxicam nanocrystal injection (specification: 1 ml: 30 mg) and the reference preparation meloxicam nanocrystal injection (Anjeso®, specification: 1 ml: 30 mg) in healthy subjects.