Vascular Headaches

Post stroke headache occurs in approximately 10-23% of all stroke patients. Its onset is shortly after experiencing a stroke, or stroke like event, and persists for at least three months. These headaches have features which resemble migraine or occur in people who have a previous history of migraine that was once infrequent. Botox is a treatment that is currently approved for the treatment of chronic migraine, that is migraine headaches occurring for at least 15 days a month for at least 3 months. Given the clinical similarity in character and frequency of post stroke headache and migraine, and the fact that stroke affects structures like the blood vessels in the brain that are also affected in migraine, this study is to investigate the possible role that Botox would have in the treatment of Post-Stroke Headache.

主要研究目的：研究单次空腹和餐后口服天方药业有限公司生产的盐酸倍他司汀片（8 mg）的药代动力学特征；以Mylan Laboratories SAS生产的盐酸倍他司汀片（Serc®，8 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。 次要研究目的：评估受试制剂（8mg）与参比制剂盐酸倍他司汀片（Serc®，8 mg）在健康受试者的安全性。

主要目的：以济南永宁制药股份有限公司生产，森淼（山东）药业有限公司持有的盐酸倍他司汀片（规格：8mg）为受试制剂，以Mylan Laboratories SAS 公司生产，Mylan Medical SAS 公司销售的盐酸倍他司汀片（商品名：Serc，规格：8mg）为参比制剂，进行空腹/餐后状态下人体生物等效性试验，评价受试制剂与参比制剂的生物等效性。次要目的：观察空腹/餐后状态下，受试制剂和参比制剂在健康受试者中的安全性。