[Translation] A randomized, open-label, two-sequence, two-period, crossover bioequivalence study of betahistine mesylate tablets in healthy subjects after single oral administration on an empty stomach or after a meal
主要目的:通过空腹/餐后试验研究,考察中国健康受试者在空腹/餐后条件下单次口服受试制剂(甲磺酸倍他司汀片,天津恒翊药业有限公司)与参比制剂(甲磺酸倍他司汀片,商品名:敏使朗®,卫材(中国)药业有限公司)后的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:评价单次口服甲磺酸倍他司汀片(6mg)受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of the test preparation (Betahistine Mesylate Tablets, Tianjin Hengyi Pharmaceutical Co., Ltd.) and the reference preparation (Betahistine Mesylate Tablets, trade name: Minshilan®, Eisai (China) Pharmaceutical Co., Ltd.) in healthy Chinese subjects after a single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test preparation and the reference preparation of Betahistine Mesylate Tablets (6 mg) taken orally in healthy Chinese subjects.