[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, two-cycle, two-crossover bioequivalence study of metoclopramide tablets (10 mg) in healthy Chinese subjects under fasting and postprandial dosing conditions.
主要研究目的:按有关生物等效性试验的规定,选择ANI Pharmaceuticals, Inc.为持证商的甲氧氯普胺片(商品名:REGLAN,规格:10mg)为参比制剂,对云鹏医药集团有限公司生产并提供的受试制剂甲氧氯普胺片(规格:10mg)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:观察健康志愿受试者口服受试制剂甲氧氯普胺片(规格:10mg)和参比制剂甲氧氯普胺片(商品名:REGLAN,规格:10mg)的安全性。
[Translation] Primary objective: In accordance with relevant bioequivalence testing regulations, metoclopramide tablets (trade name: REGLAN, strength: 10mg), manufactured by ANI Pharmaceuticals, Inc., was selected as the reference formulation. A bioequivalence study was conducted on the test formulation, metoclopramide tablets (strength: 10mg), manufactured and supplied by Yunpeng Pharmaceutical Group Co., Ltd., under both fasting and postprandial administration conditions. The study aimed to compare the absorption rate and extent of the drug in the test formulation with those in the reference formulation to determine if the differences were within acceptable limits, and to evaluate 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 metoclopramide tablets (strength: 10mg) and the reference formulation metoclopramide tablets (trade name: REGLAN, strength: 10mg) in healthy volunteers.