薁磺酸钠片在健康受试者中空腹/餐后单次口服给药、随机、开放、两序列、两周期、交叉生物等效性试验
[Translation] A randomized, open-label, two-sequence, two-period, crossover bioequivalence study of sodium azulene sulfonate tablets in healthy subjects after single oral administration on an empty stomach or after a meal
主要目的:考察中国健康受试者在空腹/餐后条件下单剂量口服薁磺酸钠片(规格:2mg)后的体内药代动力学特征,评价受试制剂(T)与参比制剂(R)的生物等效性;
次要目的:研究单剂量口服薁磺酸钠片(规格:2mg)在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of sodium azulene sulfonate tablets (specification: 2 mg) after a single oral dose in healthy Chinese subjects under fasting/postprandial conditions, and to evaluate the bioequivalence of the test preparation (T) and the reference preparation (R);
Secondary objective: To study the safety of a single oral dose of sodium azulene sulfonate tablets (specification: 2 mg) in healthy Chinese subjects.
100 Clinical Results associated with Sichuan Guokang Pharmaceutical Co., Ltd
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