[Translation] A randomized, open, single-dose, two-sequence, two-period, double-crossover bioequivalence study of trazodone hydrochloride tablets in healthy Chinese subjects after meal administration
按有关生物等效性试验的规定,选择オルガノン株式会社为持证商的盐酸曲唑酮片(商品名:RESLIN,规格:50mg)为参比制剂,对华益泰康药业股份有限公司生产并提供的受试制剂盐酸曲唑酮片(规格:50mg)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,评估两种制剂在餐后给药条件下的生物等效性。
[Translation] In accordance with the relevant provisions of bioequivalence tests, trazodone hydrochloride tablets (trade name: RESLIN, specification: 50 mg) of which Olganon Co., Ltd. is the licensee was selected as the reference preparation, and a human bioequivalence study of postprandial administration was conducted on the test preparation trazodone hydrochloride tablets (specification: 50 mg) produced and provided by Huayi Taikang Pharmaceutical Co., Ltd. to compare whether the absorption rate and degree of the drug in the test preparation were within an acceptable range with those of the reference preparation, and to evaluate the bioequivalence of the two preparations under postprandial administration conditions.