Suzhou No. 4 Pharmaceutical Factory

Using healthy Chinese subjects as subjects, a self-crossover controlled trial design was employed to determine the plasma concentration of criborone ointment in healthy subjects over time after administration of the test formulation [specification: 2% (30 g: 0.6 g)]. Corresponding pharmacokinetic parameters were estimated, and criborone ointment [trade name: Staquis®, specification: 2%] manufactured by Pharmacia and Upjohn Company LLC and licensed by Anacor Pharmaceuticals, Inc. was used as the reference formulation to evaluate the bioequivalence between the formulations and to observe the safety of criborone ointment in healthy Chinese subjects.

1. To evaluate the effectiveness of doxylamine succinate tablets in the treatment of short-term insomnia by monitoring the subjects' sleep latency through polysomnography compared with placebo. 2. To explore the optimal clinical 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.

Doxylamine succinate tablets developed by Suzhou Fourth Pharmaceutical Factory Co., Ltd. were used as the test preparation, and doxylamine succinate tablets (trade name: UNISOM) developed by Chatem, USA, were used as the reference preparation. According to the relevant provisions of bioequivalence tests, human bioavailability and bioequivalence tests were conducted under fasting state to evaluate the bioequivalence of the two preparations and the safety of doxylamine succinate tablets (25 mg) developed by Suzhou Fourth Pharmaceutical Factory Co., Ltd. and the reference preparation.