[Translation] A single-center, randomized, open-label, two-sequence, two-cycle, crossover bioequivalence trial 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] Main purpose: To investigate the in vivo pharmacokinetic characteristics of healthy subjects after taking a single dose of citalopram hydrobromide tablets (specification: 20 mg) under fasting/postprandial conditions, and to evaluate the test preparation (T) and the reference preparation (R) Bioequivalence. Secondary objective: To evaluate the safety of single-dose oral citalopram hydrobromide tablets (strength: 20 mg) of the test preparation and reference preparation in healthy Chinese subjects.