[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period, fully replicated crossover bioequivalence trial of mesalazine enteric-coated tablets (0.5g) in healthy Chinese subjects under fasting and postprandial administration conditions.
主要研究目的:按有关生物等效性试验的规定,选择Dr. Falk Pharma GmbH为持证商的美沙拉秦肠溶片(商品名:莎尔福/Salofalk,规格:0.5g)为参比制剂,对浙江贝得药业有限公司生产并提供的受试制剂美沙拉秦肠溶片(规格:0.5g)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评估两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康试验参与者口服受试制剂美沙拉秦肠溶片(规格:0.5g)和参比制剂美沙拉秦肠溶片(商品名:莎尔福/Salofalk,规格:0.5g)的安全性。
[Translation] Primary Objective: In accordance with relevant bioequivalence testing regulations, mesalazine enteric-coated tablets (trade name: Salofalk, strength: 0.5g), manufactured by Dr. Falk Pharma GmbH, was selected as the reference formulation. A human bioequivalence study was conducted on the test formulation mesalazine enteric-coated tablets (strength: 0.5g) manufactured and supplied by Zhejiang Beide Pharmaceutical Co., Ltd., under fasting and postprandial administration conditions. The study compared the absorption rate and extent of absorption of the drug in the test formulation with the reference formulation to determine if the differences were within acceptable limits, and evaluated the bioequivalence of the two formulations under fasting and postprandial administration conditions.
Secondary Objective: To observe the safety of oral administration of the test formulation mesalazine enteric-coated tablets (strength: 0.5g) and the reference formulation mesalazine enteric-coated tablets (trade name: Salofalk, strength: 0.5g) to healthy participants.