[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of cyproheptadine hydrochloride tablets (4 mg) in healthy Chinese participants 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Alfasigma S.p.A为持证商的盐酸赛庚啶片(商品名:Periactin,规格:4mg)为参比制剂,对上海理想制药有限公司生产并提供的受试制剂盐酸赛庚啶片(规格:4mg)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,评价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盐酸赛庚啶片(规格:4mg)和参比制剂盐酸赛庚啶片(商品名:Periactin,规格:4mg)的安全性。
[Translation] Primary objective: In accordance with relevant bioequivalence testing regulations, cyproheptadine hydrochloride tablets (trade name: Periactin, strength: 4mg), manufactured by Alfasigma S.p.A., were selected as the reference formulation. A human bioequivalence study was conducted on the test formulation, cyproheptadine hydrochloride tablets (strength: 4mg), manufactured and supplied by Shanghai Ideal 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 those in the reference formulation to determine if the differences were within acceptable ranges, 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, cyproheptadine hydrochloride tablets (strength: 4mg), and the reference formulation, cyproheptadine hydrochloride tablets (trade name: Periactin, strength: 4mg), in healthy participants.