健康受试者空腹/餐后条件下单次口服氢溴酸西酞普兰片的单中心、随机、开放、两序列、两周期、交叉生物等效性试验
[Translation] A single-center, randomized, open-label, two-sequence, two-period, crossover bioequivalence study of a single oral dose of citalopram hydrobromide tablets in healthy subjects under fasting/postprandial conditions
主要目的:考察健康受试者在空腹/餐后条件下单剂量口服氢溴酸西酞普兰片(规格:20mg)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:评价单剂量口服氢溴酸西酞普兰片(规格:20mg)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 pharmacokinetic characteristics of a single oral dose of Citalopram Hydrobromide Tablets (20 mg) in healthy subjects under fasting/fed conditions, and to evaluate the bioequivalence of the test preparation (T) and the reference preparation (R). Secondary objective: To evaluate the safety of a single oral dose of Citalopram Hydrobromide Tablets (20 mg) in healthy Chinese subjects.
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