盐酸雷莫司琼缓释贴片在健康受试者中单次给药的安全性、耐受性、药代动力学特征的单中心、随机、开放的I期临床研究
[Translation] A single-center, randomized, open-label phase I clinical study on the safety, tolerability, and pharmacokinetics of single-dose ramosetron hydrochloride sustained-release patches in healthy subjects
主要目的:
1. 评估健康中国成年受试者单次给予盐酸雷莫司琼缓释贴片后的安全性、耐受性。
次要目的:
1. 评估健康中国成年受试者单次给予盐酸雷莫司琼缓释贴片后体内药代动力学特征。
2. 评估健康中国成年受试者单次给予盐酸雷莫司琼缓释贴片后,该贴片的粘附性。
[Translation] the main purpose:
1. To evaluate the safety and tolerability of single administration of ramosetron hydrochloride extended-release patch in healthy Chinese adult subjects.
Secondary purpose:
1. To evaluate the in vivo pharmacokinetic characteristics of healthy Chinese adult subjects after a single administration of ramosetron hydrochloride extended-release patch.
2. To evaluate the adhesion of ramosetron hydrochloride extended-release patch after a single administration to healthy Chinese adult subjects.
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