[Translation] Pharmacokinetic test, clinical tolerance test, evaluation of efficacy and safety in the treatment of acute closed soft tissue injury (joint sprain) (Qi stagnation and blood stasis syndrome)
I期:评价健康中国受试者单次和多次给予不同剂量药物后的士的宁药代动力学特征及安全性、耐受性,评估冰栀伤痛气雾剂的安全剂量范围,确定人体最大耐受量,为制定临床使用提供依据。
II期:评价冰栀伤痛气雾剂与原剂型和安慰剂相比治疗急性闭合性软组织损伤(关节扭伤)(气滞血瘀证)的有效性及安全性。
[Translation] Phase I: Evaluate the pharmacokinetic characteristics, safety and tolerability of strychnine after single and multiple administration of different doses to healthy Chinese subjects, evaluate the safe dosage range of Bingzhi pain aerosol, determine the maximum tolerated dose of the human body, and provide a basis for clinical use.
Phase II: Evaluate the efficacy and safety of Bingzhi pain aerosol compared with the original dosage form and placebo in the treatment of acute closed soft tissue injury (joint sprain) (Qi stagnation and blood stasis syndrome).