Wuhan Aimin Pharmaceutical Co. Ltd.

To study the pharmacokinetic characteristics of doxepin hydrochloride tablets (3 mg) developed and produced by Wuhan Aimin Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; doxepin hydrochloride tablets (Silenor, 3 mg) produced by Pernix therapeutics, LLC were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

To evaluate the efficacy and safety of sodium aescinate enteric-coated capsules in the treatment of edema caused by lower extremity venous insufficiency, and to observe gastrointestinal irritation, including observation and evaluation of clinical efficacy, clinical adverse events, and laboratory test abnormalities, to provide a scientific basis for the drug to be approved for marketing.

To evaluate the effectiveness and safety of sodium aescinate enteric-coated capsules in the treatment of postoperative limb swelling, and to observe gastrointestinal irritation, including observation and evaluation of clinical efficacy, clinical adverse events, and laboratory test abnormalities, to provide a scientific basis for the drug to be approved for marketing.