[Translation] A single-dose, open-label, randomized, two-period, two-sequence crossover study to evaluate the bioequivalence of ebastine 10 mg film-coated tablets produced by a fluidized bed drying process and a static oven drying process in healthy subjects under fasting and fed conditions
本试验旨在评价单次口服由IFA使用托盘烘箱干燥工艺生产的依巴斯汀10 mg片剂与使用流化床系统干燥工艺生产的依巴斯汀10 mg片剂后,这两种制剂的生物等效性。食物与药物同服,可能会影响药物的生物利用度。因此,本试验将分别在空腹和餐后条件下评估受试制剂和参比制剂的生物等效性。
[Translation] This study aims to evaluate the bioequivalence of ebastine 10 mg tablets produced by IFA using a tray oven drying process and ebastine 10 mg tablets produced using a fluidized bed system drying process after a single oral administration. Taking food with a drug may affect the bioavailability of the drug. Therefore, this study will evaluate the bioequivalence of the test and reference products under fasting and fed conditions, respectively.