[Translation] A multicenter, randomized, double-blind, placebo, parallel-controlled phase III clinical trial evaluating the efficacy and safety of doxylamine succinate tablets in the treatment of short-term insomnia
1. 与安慰剂相比,通过多导睡眠仪监测受试者入睡潜伏期,评价琥珀酸多西拉敏片治疗短期失眠的有效性。
2. 探索琥珀酸多西拉敏片治疗短期失眠的临床最佳剂量。
3. 评价琥珀酸多西拉敏片治疗短期失眠的安全性。
[Translation] 1. To evaluate the efficacy of doxylamine succinate tablets in the treatment of short-term insomnia by monitoring the sleep onset latency of subjects by polysomnography compared with placebo.
2. To explore the clinical optimal dose of doxylamine succinate tablets in the treatment of short-term insomnia.
3. To evaluate the safety of doxylamine succinate tablets in the treatment of short-term insomnia.