Anastomotic ulcer

The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (
1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duodenal ulcers and esophageal ulcers. This advancement has the potential not only to improve patient outcomes through less invasive methods, but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies.

主要目的：研究空腹及餐后状态下单次口服受试制剂奥美拉唑肠溶片（规格：20 mg，浙江京新药业股份有限公司生产）与参比制剂奥美拉唑肠溶片（Omepral®，规格：20 mg，太陽ファルマ株式会社持证）在健康成年参与者体内的药代动力学，评价两种制剂是否具有生物等效性。 次要目的：研究受试制剂奥美拉唑肠溶片（规格：20 mg）和参比制剂奥美拉唑肠溶片（Omepral®，规格：20 mg）在健康成年参与者中的安全性。

主要目的：以石药集团中诺药业（石家庄）有限公司生产的兰索拉唑肠溶胶囊为受试制剂，以天津武田药品有限公司生产的兰索拉唑肠溶胶囊（商品名：达克普隆®）为参比制剂，按生物等效性试验的相关规定，比较兰索拉唑肠溶胶囊在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。 次要目的：评价健康受试者单次空腹/餐后口服兰索拉唑肠溶胶囊受试制剂和参比制剂后的安全性。