[Translation] Randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover bioequivalence trial of Dronedarone Hydrochloride Tablets (400 mg) in Chinese healthy subjects after a meal.
主要研究目的:按有关生物等效性试验的规定,选择Sanofi Aventis U.S.,LLC为持证商的盐酸决奈达隆片(商品名:迈达龙,规格:400mg)为参比制剂,对石家庄四药有限公司生产的受试制剂盐酸决奈达隆片(规格:400mg)进行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,评价两种制剂在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盐酸决奈达隆片(规格:400mg)和参比制剂盐酸决奈达隆片(商品名:迈达龙,规格:400mg)的安全性。
[Translation] Main research purpose: According to the regulations on bioequivalence testing, dronedarone hydrochloride tablets (trade name: Metaron, specification: 400mg) of Sanofi Aventis U.S., LLC, which is the licensee, was selected as the reference preparation. The test preparation dronedarone hydrochloride tablets (specification: 400mg) produced by Siyao Co., Ltd. were subjected to postprandial administration human bioequivalence tests to compare the absorption speed and extent of the drug in the test preparation with the reference preparation. To evaluate whether the bioequivalence of the two formulations is within the acceptable range under postprandial administration conditions. Secondary research purpose: To observe the safety of the test preparation Dronedarone Hydrochloride Tablets (specification: 400mg) and the reference preparation Dronedarone Hydrochloride Tablets (trade name: Metaron, Specification: 400mg) taken orally by healthy volunteers. sex.