[Translation] A randomized, open-label, two-sequence, two-cycle, double-crossover design of a randomized, open-label, bioequivalence study of single oral meloxicam tablets in Chinese healthy volunteers
研究空腹及餐后单次口服美洛昔康片受试制剂(普利洛®,7.5 mg/片,江苏飞马药业有限公司)与美洛昔康片参比制剂(MOBEC ®,7.5 mg/片,Boehringer Ingelheim Pharma GmbH& Co.KG)后美洛昔康在中国健康志愿者体内的PK(Pharmacokinetics,药代动力学)行为,评价空腹及餐后口服两种制剂的生物等效性。
次要目的:
评价中国健康志愿者单次口服美洛昔康片受试制剂和参比制剂后的安全性。
[Translation] To study the test preparation of meloxicam tablets on an empty stomach and after a meal (Prilox®, 7.5 mg/tablet, Jiangsu Feima Pharmaceutical Co., Ltd.) and the reference preparation of meloxicam tablets (MOBEC ®, 7.5 mg) /tablet, Boehringer Ingelheim Pharma GmbH & Co. KG), the PK (Pharmacokinetics, pharmacokinetics) behavior of meloxicam in Chinese healthy volunteers, and the bioequivalence of the two preparations after fasting and after meals.
Secondary purpose:
To evaluate the safety of Chinese healthy volunteers after a single oral administration of the test preparation and reference preparation of meloxicam tablets.